Product code DYB— Cardiovascular
CATHETER INTRODUCER
- Advisory panel
- Cardiovascular
- Total cleared
- 705
Clearances under product code DYB — page 2
101–200 of 705- K192769 — Impella CP Introducer
- K192106 — AcQRef Introducer Sheath
- K191871 — 15F iSLEEVE Introducer Set, 14F iSLEEVE Introducer Set
- K191546 — Epicardial Access System
- K191190 — Steerable Introducer
- K183066 — The POWERWAND Safety Introducer with an Extended Dwell Catheter made of ChronoFlex C® with BioGUARD Technology-3 Fr, 4 Fr, and 5 Fr Model
- K190628 — FlexSeal Introducer Sheath with Hydrophilic Coating
- K183655 — VersaCross Transseptal Sheath
- K190974 — D'Vill Introducer
- K190941 — BioCardia 8.5 F Avance Steerable lntroducer
- K190644 — Guide Sheath
- K190369 — M-Y Sheath
- K190688 — VersaCross Steerable Sheath, VersaCross Transseptal Dilator
- K181817 — transGlideXT Expandable Introducer
- K190098 — Endophys Pressure Sensing Sheath
- K190184 — iSLEEVE Introducer Set
- K181463 — DuraSheath Introducer Sheath System
- K181031 — TSI Transseptal Introducer
- K180620 — Endophys Pressure Sensing Sheath Kit
- K181088 — TSP Crosser Transseptal Access System
- K182243 — The CVC WAND Safety Introducer with Valved Peelable Sheath
- K181592 — RAIN Sheath Transradial
- K181237 — Glidesheath Slender Tibial Pedal Kit
- K181855 — RadialSeal Introducer Kit
- K180785 — iSLEEVE Introducer Set
- K171609 — Check-Flo Performer Introducer Micropuncture Radial Artery Access Set
- K180913 — VSI Micro-Introducer Kit
- K173831 — Glidesheath Slender
- K172980 — Micropuncture Pedal Access Set
- K180081 — RAILWAY Sheathless Access System
- K171988 — Performer Guiding Sheath
- K171820 — Transjugular Liver Access Sets
- K172331 — Type I, Type II, Type III, Type IV
- K173750 — Prelude IDeal Hydrophilic Sheath Introducer
- K171557 — AcQRef Introducer Sheath
- K173287 — Elite HV Radial
- K171275 — Micropuncture Introducer Set, Micropuncture Introducer Set with Push-Plus Design, Micropuncture Introducer Set with Silhouette Transitionless Design, Micropuncture Introducer Set with Silhouette Transitionless Design and Push-Plus Design
- K171866 — Sentrant Introducer Sheath with Hydrophilic Coating
- K173685 — Peel-Away Introducer Set
- K173399 — Endophys Pressure Sensing Sheath Kit- 8F
- K172995 — Destination Carotid Guiding Sheath, Destination Peripheral Guiding Sheath, Destination Renal Guiding Sheath
- K173068 — Performer Introducer
- K171206 — D'Vill Introducer
- K171491 — R2P Destination Slender Guiding Sheath
- K172099 — Shoocin Introducer Kit
- K170020 — Peel-Away Introducer Set
- K172117 — Prelude Pursuit Splittable Sheath Introducer
- K171853 — Liver Access and Biopsy Sets
- K171999 — Performer Introducer
- K170997 — CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath
- K170775 — Mini Stick ENVI Non-Vascular Introducer Kit
- K170695 — VenaCure EVLT NeverTouch Direct Introducer Sheath
- K170831 — EpiAccess System
- K171081 — Guider Catheter Introducer
- K170668 — HeartSpan Steerable Sheath Introducer
- K160721 — Vado Steerable Sheath
- K170373 — Flextra Steerable Introducer
- K163268 — FlexCath Select Steerable Shealth and Dilator
- K162427 — Vado Bi-Directional Steerable Sheath
- K162097 — InTRAkit
- K162322 — the POWERWAND Safety Introducer with an Extended Dwell Catheter, 3Fr. Model
- K162769 — Pinpoint GT Introducer Needle
- K153771 — TXM Guiding Sheath
- K162184 — Edwards eSheath Introducer Set
- K153494 — HQS Introducer (Model 2064-HQS)
- K152913 — GORE TIPS Set, GORE TIPS Sheath, GORE TIPS Needle
- K161659 — FlexSeal Introducer Sheath with Hydrophilic Coating
- K153533 — Tearaway Introducer Sheath, MicroSlide Tearaway Introducer
- K161183 — Halo One Thin-Walled Guiding Sheath
- K161102 — Nanostim Introducer Kit
- K160254 — GORE DrySeal Flex Introducer Sheath
- K160716 — The Nanostim Introducer Kit
- K152194 — transGlide Expandable Introducer
- K153430 — Flexor Tuohy-Borst Side-Arm Introducers Shuttle Select
- K160272 — Endophys Pressure Sensing Sheath Kit
- K153246 — PTFE Super Sheath Introducer 2.1
- K153197 — Fortress Introducer Sheath SYstem
- K152498 — SoloPath Re-Collapsible Access System
- K151936 — Steerable Intracardiac Catheter Introducer Kit and Transseptal Needle
- K152173 — Glidesheath
- K152225 — Edwards eSheath Introducer Set
- K152381 — Prelude SNAP Splittable Hydrophilic Sheath Introducer
- K152177 — SonoStik IV Guide Wire Introducer
- K151951 — Destino Reach
- K152116 — 5.5 F Worley Advanced LVI Lateral Vein Introducer
- K152044 — Flexor Radial Hydrophilic Introducer Access Set
- K152054 — Confida Adaptive Sheath
- K142829 — Flexor Tuohy-Borst Side-Arm Introducer, Ansel Modification; Flexor Check-Flo Introducer, Ansel Modification; Flexor Check-Flo Introducers, Ansel Modification with High-Flex Dilator and Hydrophilic Coating; Flexor Check-Flo Introducer Balkin Up and Over Contralateral Design; Flexor Up and Over Balkin Contralateral Introducer; Flexor Check-Flo Introducer, Raabe Modification; Flexor Check-Flo Performer Introducer
- K142819 — Shuttle SL Flexor Tuohy-Borst Side-Arm Introducer Set
- K142357 — DuraSheath Introducer Sheath System
- K150257 — PreludeEASE Hydrophilic Sheath Introducer
- K150186 — Chariot Guiding Sheath
- K142445 — PINPOINT GT SAFETY INTRODUCER NEEDLE
- K143255 — Prelude SNAP Splittable Sheath Introducer
- K141275 — ENDOPHYS PRESSURE SENSING SHEATH KIT
- K141969 — FIRSTSTIC N INTRODUCER
- K140793 — NANOSTIM INTRODUCER KIT
- K140768 — TYPE I BRILLIANT INTRODUCER KIT, TYPE II BRILLIANT INTRODUCER KIT, TYPE III BRILLIANT INTRODUCER KIT, TYPE IV BRILLIANT
- K142183 — GLIDESHEATH SLENDER
- K142684 — FlexCath Select Steerable Sheath (10 French)
Data sourced from openFDA. This site is unofficial and independent of the FDA.