Vascular Solutions, Inc.
Vascular Solutions, Inc. holds FDA 510(k) medical device clearances, first cleared 2002, most recent 2018, with 17 FDA device recalls on record.
Top product codes for Vascular Solutions, Inc.
FDA recalls by Vascular Solutions, Inc.
10 most recent of 17- Z-0111-2021 — Langston Dual Lumen Catheter.
- Z-0113-2021 — Langston Dual Lumen Catheter.
- Z-0110-2021 — Langston Dual Lumen Catheter
- Z-0112-2021 — Langston Dual Lumen Catheter.
- Z-1747-2020 — Langston Dual Lumen Catheter 6F Model 5540. For delivery of contrast medium in angiographic studies
- Z-2249-2018 — Drainer(R) Centesis Catheters: (a) REF 8810, 5F x 9cm (b) REF 8811, 6F x 9cm (c) REF 8812, 5F x 15cm Product The Drainer centesis catheter is intended for use in percutaneous fluid aspirations and small volume drainage procedures.
- Z-2224-2017 — Venture RX Catheter, Model 5820; Venture OTW Catheter, Model 5821; Venture CS Catheter, Model 5822. Sterilized using ethylene oxide, Rx Only. The Venture catheter is indicated for directing, steering, controlling, and supporting a guidewire to access discrete regions of the coronary and peripheral vasculature. The OTW versions (Models 5821 and 5822) may also be used for manual delivery of saline solution or diagnostic contrast agents
- Z-2180-2017 — Dolphin Inflation Device, REF 0185NA. Rx only, Sterilized using Ethylene Oxide. DOLPHIN is a single-use, sterile inflation device used in cardiovascular procedures to pressurize (inflate) and depressurize (deflate) balloon catheters. The device itself consists of two components - the inflation device and large volume syringe (30 cc). The manually operation of the DOLPHIN is achieved by the manipulation of a large handle to drive a piston housed within the body of the device. Careful and controlled inflation is achieved by rotating the handle clockwise. During inflation a unique cam locking mechanism maintains pressure even if the user lets go of the device. Instantaneous deflation, regardless of balloon size, is made possible by the release of the dual locks located on device as well as a large, 30 cc syringe that is sold with each Dolphin Inflation Device. All the while during inflation or deflation pressure is displayed and can be monitored on a large analog gauge mounted on top of the device.
- Z-1250-2017 — GrebSet Micro-Introducer Kit, model 7941, Sterilized with Ethylene Oxide. Product Usage: The GrebSet micro-introducer kit is intended to facilitate the percutaneous placement of guidewires in the vascular system and for delivery of contrast media to vascular sites.
- Z-0055-2017 — Vascular Solutions Twin-Pass .023" Dual Access Catheter, model 5230. Sterilized with Ethylene Oxide. The Twin-Pass dual access catheter is a dual lumen catheter designed for use in the coronary and/or peripheral vasculature. The Twin-Pass catheter (Models 5200 and 5230) consists of an over-the-wire (OTW) lumen that runs the length of the catheter and a rapid exchange (RX) delivery lumen on the distal segment. The Twin-Pass catheter has a working length of 135cm and is compatible with various guidewire diameters. Model 5200 also has hydrophilic coating on the distal 18cm of the catheter. The Twin-Pass catheter has white positioning marks located at 95cm (single mark) and 105cm (double marks) from the distal tip, respectively. The Twin-Pass catheter has a marker band located 1mm from the distal tip. Model 5200 contains a second marker band located 11mm from the distal tip to identify the distal end of the OTW lumen.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Vascular Solutions, Inc.
1–100 of 103- K182232 — Octane Mechanical Thrombectomy System
- K181647 — Bandit guidewire
- K180913 — VSI Micro-Introducer Kit
- K180088 — TrapLiner catheter
- K180128 — Warrior 14 guidewire
- K173891 — Gel-Bead (600-800 micron) - 1 ml sphere volume, Gel-Bead (600-800 micron) - 2 ml sphere volume
- K173532 — Raider Guidewire
- K173266 — Octane aspiration system
- K170544 — Langston dual lumen catheter
- K171946 — Gel-Bead
- K172090 — GuideLiner V3 Catheter
- K171335 — Venture 038 catheter
- K163307 — Expro Elite Snare, Sympro Elite Snare
- K161901 — TrapLiner catheter
- K162467 — Twin-Pass Torque
- K163444 — Spectre guidewire
- K161702 — Endura guidewire
- K162272 — Fluent inflation device
- K161336 — VSI StraitSet micro-introducer kit
- K152387 — Fluent Inflation Device
- K151234 — R350 guidewire
- K142065 — TURNPIKE CATHETER
- K143038 — Gel-Block 10X embolization pledgets
- K133237 — GEL-BEAD EMBOLIZATION SPHERES
- K132789 — FLIP INTRODUCER ACCESS KIT
- K133501 — LEADLINER CS LEAD DELIVERY SYSTEM
- K120707 — SWITCH-IT CATHETER
- K113266 — GEL-BLOCK EMBOLIZATION PLEDGETS
- K112100 — M2 NAVIGATION CATHETER AND GUIDELINER NAVIGATION CATHETER
- K113140 — VARI-LASE WIREFIBER LASER FIBER
- K112082 — GUIDELINER V2 CATHETER
- K112631 — VSI GUIDEWIRE
- K112571 — XL EXTRACTION CATHETER
- K111334 — BENELLI ACCESS DEVICE
- K102212 — D-STAT DRY SILVER; D-STAT DRY CLEAR SILVER; D-STAT DRY WRAP SILVER; THROMBIX SILVER
- K101604 — VSI MICRO-INTRODUCER SETS (REGULAR, STIFFEN), MODELS 7197V-7209V, 7240V-7256V, 7259V, 7230V, 7231V, 7260V, 7274V
- K103405 — PRONTO V4 EXTRACTION CATHETER 5.5F; PRONTO V4 EXTRACTION CATHETER 6F; PRONTO V4 EXTRACTION 7F
- K101659 — SUPERCROSS MICROCATHETER (130 CM), SUPERCROSS MICROCATHETER (150 CM) MODEL 5300, 5301
- K101625 — COHEN CROSSOVER CATHETER
- K100093 — VSI TORQUE DEVICE
- K093502 — VARI-LASE ENDOVENOUS LASER CONSOLE
- K091750 — GUIDELINER CATHETER, MODELS 5571, 5572, 5573
- K092563 — GATOR CLIPSEAL PLUG
- K092612 — D-STAT RAD-BAND, RAD-BAND, MODELS 3501, 3505
- K091551 — VARI-LASE PLATINUM BRIGHT TIP LASER FIBER
- K090977 — PIGGYBACK WIRE CONVERTER
- K091345 — GOPHER GOLD CATHETER, MODEL 5620
- K083784 — PRONTO V3 EXTRACTION CENTER, MODEL 5003, PRONTO LP EXTRACTION CATHETER, MODEL 5010, SKYWAY RX SUPPORT CATHETER,
- K081846 — GREBSET MICRO-INTRODUCER KIT, MODELS 7950, 7951
- K082337 — MINNIE SUPPORT CATHETER
- K080022 — GEL-SPONGE ENT, ABSORBABLE GELATIN SPONGE, USP
- K083190 — D-STAT DRY WRAP HEMOSTATIC BANDAGE, MODEL: 3015
- K073585 — INNERCHANGE MICRO-INTRODUCER CATHETER, MODELS 7900, 7901, 7902, 7903, 7904 AND 7905
- K080104 — VARI-LASE ENDOVENOUS LASER CONSOLE, MODEL 7542
- K073200 — GANDRAS INTRAVASCULAR CATHETER, MODELS 5580, 5581 AND 5582
- K072332 — VARI-LASE WIRE FIBER
- K072810 — PRONTO LOW PROFILE (LP) EXTRACTION CATHETER, MODEL 5010
- K073264 — D-STAT DRY CLEAR HEMOSTATIC BANDAGE, MODEL 3005
- K072618 — TWIN-PASS OTW CATHETER, MODEL 5201
- K072117 — THROMBIX PATCH THROMBIN HEMOSTASIS PATCH
- K071727 — QXT EXTRACTION CATHETER
- K070938 — THROMBI-PASTE THROMBIN/GELATIN POWDER PASTE HEMOSTAT
- K070403 — PRONTO .035 EXTRACTION CATHETER
- K070372 — GOPHER 2F SUPPORT CATHETER, MODEL 5600 AND GOPHER 3F SUPPORT CATHETER, MODEL 5610
- K070216 — VARI-LASE BRIGHT TIP FIBER
- K063871 — D-STAT HANDLE, MODEL 8500-053
- K063860 — THROMBIGEL THROMBIN/GELATIN FOAM HEMOSTAT
- K063851 — AUTO-FILL SYRINGE KIT, MODEL 7600
- K062877 — TWIN-PASS .023 DUAL ACCESS CATHETER, MODEL 5230
- K062627 — INNERCHANGE MICRO-INTRODUCER CATHETER, MODELS 7900 THROUGH 7905
- K063371 — PRONTO V3 EXTRACTION CATHETER, MODEL 5003
- K062822 — VARI-LASE ENDOVENOUS LASER CONSOLE, MODEL 7500
- K061219 — D-STAT DRY HEMOSTATIC BANDAGE
- K061565 — LANGSTON DUAL LUMEN CATHETER
- K060327 — VASCULAR SOLUTIONS TWIN-PASS DUAL ACCESS CATHETER AND SKYWAY SUPPORT CATHETER
- K053644 — THROMBIGEL THROMBIN/GELATIN FOAM HEMOSTAT
- K052258 — VASCULAR SOLUTIONS SKYWAY SUPPORT CATHETER
- K052257 — VASCULAR SOLUTIONS TWIN-PASS DUAL ACCESS CATHETER
- K053054 — THROMBIX 3X3 HEMOSTATIC PAD
- K052232 — VASCULAR SOLUTIONS PRONTO V3 EXTRACTION CATHETER
- K051193 — VASCULAR SOLUTIONS PRONTO SHORT EXTRACTION CATHETER
- K051287 — VARI-LASE ENDOVENOUS LASER PROCEDURE KIT
- K051395 — LANGSTON DUAL LUMEN PRESSURE MONITORING CATHETER
- K050146 — VASCULAR SOLUTIONS D-STAT CLAMP ACCESSORY
- K050168 — LANGSTON DUAL LUMEN PRESSURE MONITORING CATHETER
- K050511 — THROMBIGEL THROMBIN/GELATIN FOAM HEMOSTAT
- K050021 — VASCULAR SOLUTIONS VARI-LASE ENDOVENOUS LASER PROCEDURE KIT
- K050133 — D-STAT RADIAL HEMOSTATIC BAND
- K042937 — MODIFICATION TO VASCULAR SOLUTIONS PRONTO EXTRACTION CATHETER
- K043019 — VASCULAR SOLUTIONS SCLERO-KIT
- K041909 — VASCULAR SOLUTIONS LANGSTON DUAL LUMEN PIGTAIL CATHETER (DLP)
- K040730 — VASCULAR SOLUTIONS D-STAT CLAMP HEMOSTATIC CLAMP
- K040510 — VASCULAR SOLUTIONS D-STAT DRY 3X3 HEMOSTATIC PAD
- K033721 — VASCULAR SOLUTIONS AUTO-FILL SYRINGE KIT
- K040118 — VASCULAR SOLUTIONS D-STAT DRY HEMOSTATIC BANDAGE, THE D-STAT RADIAL HEMOSTATIC BAND AND THE D-STAT 2 DRY HEMOSTATIC
- K032763 — VASCULAR SOLUTIONS PRONTO EXTRACTION CATHETER
- K033709 — VASCULAR SOLUTIONS D-STAT 2 DRY HEMOSTATIC BANDAGE
- K033237 — VASCULAR SOLUTIONS VARI-LASE ENDOVENOUS LASER CONSOLE
- K032805 — MODIFICATION TO VASCULAR SOLUTIONS VARI-LASE ENDOVENOUS LASER PROCEDURE KIT
- K030836 — D-STAT-DRY HEMOSTATIC BANDAGE; D-STAT RADIAL HEMOSTATIC BANDAGE
Data sourced from openFDA. This site is unofficial and independent of the FDA.