Product code DYB— Cardiovascular
CATHETER INTRODUCER
- Classification name
- Introducer, Catheter
- Device class
- Class 2
- Regulation
- 21 CFR 870.1340
- Advisory panel
- Cardiovascular
- Total cleared
- 706
- First cleared
- Most recent
Clearances under product code DYB — page 3
201–300 of 706- K142684 — FlexCath Select Steerable Sheath (10 French)
- K142245 — EpiAccess System
- K140543 — PRELUDEEASE HYDROPHILIC SHEATH INTRODUCER
- K132592 — FLEXOR RADIAL HYDROPHILIC INTRODUCER ACCESS SET
- K141696 — EDWARDS ESHEATH INTRODUCER SET
- K140338 — CREGANNA TACTX LOTUS INTRODUCER SET (SMALL), CREGANNA TACTX LOTUS INTRODUCER SET (LARGE)
- K140028 — GALT VTI LOW INSERTION VALVE TEARAWAY INTRODUCER
- K140513 — MERIT SAFETY INTRODUCER NEEDLE
- K140917 — INTRODUCER, MODEL ADELANTE MAGNUM
- K133114 — MICROPUNCTURE INTRODUCER SET
- K140641 — VESSIX GUIDE SHEATH 7F, 45 CM, RDC, VESSIX GUIDE SHEATH 7F, 45CM, LIMA
- K140871 — AXERA 2 ACCESS SYSTEM
- K140287 — AXERA RX ACCESS SYSTEM
- K132617 — MEDTRONIC INPUT PS INTRODUCER
- K132789 — FLIP INTRODUCER ACCESS KIT
- K140406 — DESTINO TWIST, STEERABLE GUIDING SHEATH
- K140420 — VADO STEERABLE SHEATH
- K140201 — AXERA 2 ACCESS SYSTEM
- K140398 — EMBOL-X INTRODUCER SHEATH
- K140327 — ULTIMUM EV HEMOSTASIS INTRODUCER
- K131627 — CATHETER INTRODUCER SHEATH
- K133296 — XCATH
- K130633 — INTRODUCER SETS, MODEL ADELANTE RADIAL
- K132720 — HEARTSPAN FIXED CURVE BRAIDED TRANSSEPTAL SHEATH
- K140015 — CARDIOSOLUTIONS DEXTERITY STEERABLE INTRODUCER
- K123475 — SHOOCIN INTRODUCER KIT
- K132498 — VALVED TEARAWAY INTRODUCER GENERATION II
- K130730 — V-STICK VASCULAR ACCESS SET
- K132030 — MICRA INTRODUCER SHEATH WITH HYDROPHILIC COATING
- K132164 — HEARTSPAN STEERABLE INTRODUCER KIT
- K131148 — THE CVC WAND SAFETY INTRODUCER WITH VALVED PEELABLE SHEATH
- K132263 — AXERA 2 ACCESS SYSTEM
- K130687 — 2F & 3F VASCU-SHEATH TEARAWAY INTRODUCER
- K131144 — AMECO SHEATH INTRODUCER
- K131079 — CREGANNA-TACTX STEERABLE SHEATH SET SYMMETRIC
- K130855 — PTFE SUPER SHEATH INTRODUCER
- K123714 — EDWARDS EMBOL-X INTRODUCER SHEATH
- K131332 — CARDIOSOLUTIONS PERCU-PRO STEERABLE INTRODUCER
- K131300 — THE POWERWAND SAFETY INTRODUCER WITH AN EXTENDED DWELL CATHETER
- K124046 — VALVED TEARAWAY INTRODUCER GENERATION II
- K130559 — MOBICATH BI-DIRECTIONAL GUIDING SHEATH
- K121404 — SOLOPATH RE-COLLAPSIBLE ACCESS SYSTEM
- K123990 — SENTRANT INTRODUCER SHEATH WITH HYDROPHILIC COATING
- K123430 — MICROSLIDER TEARAWAY INTRODUCER SET
- K123618 — AXERA 2 ACCESS SYSTEM
- K123974 — PERCUTANEOUS INTRODUCER KIT
- K123235 — EQUAFLOW MULTIVALVE INFUSION CATHETER
- K122431 — HEARTSPAN STEERABLE INTRODUCER KIT
- K123135 — AXERA 2 ACCESS SYSTEM MODEL AXE200
- K122926 — SUREFLEX STEERABLE GUIDING SHEATH KIT
- K123334 — REPROCESSED STEERABLE INTRODUCER
- K122854 — ARROW GLIDETHRU PEEL-AWAY SHEATH/DILATOR INTRODUCER
- K122958 — DELIVERY SHEATH, MODEL ADELANTE BREEZEWAY
- K122960 — STEERABLE GUIDING SHEATH, MODEL ADELANTE DESTINO
- K122980 — GLIDESHEATH SLENDER MODEL RM* ES6J10HQS, GLIDESHEATH SLENDER MODEL RM* ES6F16HQ, GLIDESHEATH SLENDER MODEL RM * RS6J10PQ
- K121234 — GORE(R) DRYSEAL SHEATH WITH HYDROPHILIC COATING
- K120617 — PTFE SUPER SHEATH INTRODUCER
- K121504 — SUPER SHEATH INTRODUCER SHEATH AND SUPER SHEATH INTRODUCER SHEATH SETS
- K122084 — INTRODUCER SET, MODEL ADELANTE-S SERIES
- K111603 — LINEBACKER(TM) TRANSSEPTAL INTRODUCER, 53CM / 62CM / 72CM
- K121185 — EDWARDS PERCUTANEOUS SHEATH INTRODUCER
- K122190 — PRELUDE 7F SHORT SHEATH INTRODUCER
- K120158 — CORONARY SINUS GUIDE AND LATERAL VEIN INTRODUCER KITS
- K113849 — HQS INTRODUCER
- K121748 — THE POWERWAND SAFETY INTRODUCER WITH AND EXTENDED DWELL
- K120459 — STEERABLE GUIDING SHEATH, MODEL ADELANTE DESTINO
- K121521 — AXERA ACCESS SYSTEM
- K120428 — GORE DRYSEAL SHEATH
- K112398 — TRIV(TM) VALVED TEARAWAY INTRODUCER, TIRV(TM) VALVED TEARAWAY INTRODUCER WITH SIDE PORT
- K112887 — UPSTREAM NEEDLE HOLDER, UPSTREAM NEEDLE HOLDER WITH SHUT-OFF CONNECTOR
- K112407 — SMITH MEDICAL PEEL-AWAY SHEATH INTRODUCERS
- K120212 — AFX INTRODUCER SYSTEM
- K113196 — VASCULAR SONO
- K110051 — RADIALSOURCE TRANSRADIAL ACCESS INTRODUCER KIT
- K112554 — TRANSRADIAL ARTERY ACCESS DEVICES
- K102925 — NEXGEN EXPANDABLE CATHETER
- K113110 — AXERA ACCESS SYSTEM
- K111606 — PINNACLE PRECISION ACCESS SYSTEM
- K111943 — AGILLS PF DELIVERY SYSTEM
- K111417 — THE POWERWAND (R) SAFETY INTRODUCER WITH AN EXTENDED DWELL CATHETER
- K111747 — ENDOLOGIX AFX INTRODUCER SYSTEM
- K111138 — THE PICC WAND (R) PEELABLE SAFETY INTRODUCER
- K111092 — ENGAGE/ENGAGE TR INTRODUCERS
- K110090 — AFX INTRODUCER SYSTEM
- K110450 — AGILIS NXT STEERABLE INTRODUCER
- K103083 — AGILIS ES STEERABLE INTRODUCER
- K102948 — TORFLEX TRANSSEPTAL GUIDING SHEATH
- K101422 — THE POWER WAND SAFETY INTRODUCER WITH AN EXTENDED DWELL CATHETER
- K100799 — FORTRESS INTRODUCER SHEATH SYSTEM MODEL 358813, 358814, 358815
- K103143 — ARSTASIS ONE LATCHWIRE ACCESS SYSTEM
- K101604 — VSI MICRO-INTRODUCER SETS (REGULAR, STIFFEN), MODELS 7197V-7209V, 7240V-7256V, 7259V, 7230V, 7231V, 7260V, 7274V
- K101784 — MOBICATH BI-DIRECTIONAL GUIDING SHEATH MODEL 1000182-XXX
- K102540 — PTFE PORTABLE INTRODUCER
- K101497 — DELIVERY SHEATH, MODEL ADELANTE BREEZEWAY
- K102728 — ARSTASIS ACCESS SYSTEM
- K101883 — 6F ENGAGE/ENGAGE TR INTRODUCER
- K101150 — PICC WAND PEELABLE SAFETY INTRODUCER
- K100819 — THE SOLOPATH BALLOON EXPANDABLE TRANSFEMORAL INTRODUCER
- K102008 — GLIDESHEATH
- K093877 — RETROFLEX 3 INTRODUCER SHEATH SET, MODELS 9120S23 AND 9120S26
Data sourced from openFDA. This site is unofficial and independent of the FDA.