FDA Product Code
FDA Product Code DYB — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.1340
510(k) Clearances — 706 records · page 3 of 8
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K142684 | FlexCath Select Steerable Sheath (10 French) | Medtronic Cryocath, LP | 2014-11-06 | Traditional | PDF ↗ |
| K142245 | EpiAccess System | Epiep, Inc. | 2014-10-29 | Traditional | PDF ↗ |
| K140543 | PRELUDEEASE HYDROPHILIC SHEATH INTRODUCER | Merit Medical Systems, Inc. | 2014-10-16 | Traditional | PDF ↗ |
| K132592 | FLEXOR RADIAL HYDROPHILIC INTRODUCER ACCESS SET | Cook, Inc. | 2014-10-09 | Traditional | PDF ↗ |
| K141696 | EDWARDS ESHEATH INTRODUCER SET | Edwards Lifesciences | 2014-09-18 | Traditional | PDF ↗ |
| K140338 | CREGANNA TACTX LOTUS INTRODUCER SET (SMALL), CREGANNA TACTX LOTUS INTRODUCER SET (LARGE) | Creganna-Tactx Medical | 2014-08-27 | Traditional | PDF ↗ |
| K140028 | GALT VTI LOW INSERTION VALVE TEARAWAY INTRODUCER | Galt Medical Corp. | 2014-08-21 | Traditional | PDF ↗ |
| K140513 | MERIT SAFETY INTRODUCER NEEDLE | Merit Medical Systems, Inc. | 2014-07-09 | Traditional | PDF ↗ |
| K140917 | INTRODUCER, MODEL ADELANTE MAGNUM | Oscor, Inc. | 2014-07-09 | Traditional | PDF ↗ |
| K133114 | MICROPUNCTURE INTRODUCER SET | Cook Incorporated | 2014-07-03 | Traditional | PDF ↗ |
| K140641 | VESSIX GUIDE SHEATH 7F, 45 CM, RDC, VESSIX GUIDE SHEATH 7F, 45CM, LIMA | Boston Scientific Corporation | 2014-07-03 | Traditional | PDF ↗ |
| K140871 | AXERA 2 ACCESS SYSTEM | Arstasis, Inc. | 2014-06-06 | Special | PDF ↗ |
| K140287 | AXERA RX ACCESS SYSTEM | Arstasis, Inc. | 2014-05-16 | Traditional | PDF ↗ |
| K132617 | MEDTRONIC INPUT PS INTRODUCER | Medtronic, Inc. | 2014-04-30 | Traditional | PDF ↗ |
| K132789 | FLIP INTRODUCER ACCESS KIT | Vascular Solutions, Inc. | 2014-04-17 | Traditional | PDF ↗ |
| K140406 | DESTINO TWIST, STEERABLE GUIDING SHEATH | Oscor, Inc. | 2014-04-17 | Special | PDF ↗ |
| K140420 | VADO STEERABLE SHEATH | Kalila Medical, Inc. | 2014-04-01 | Traditional | PDF ↗ |
| K140201 | AXERA 2 ACCESS SYSTEM | Arstasis, Inc. | 2014-03-28 | Traditional | PDF ↗ |
| K140398 | EMBOL-X INTRODUCER SHEATH | Edwards Lifesciences, LLC | 2014-03-19 | Special | PDF ↗ |
| K140327 | ULTIMUM EV HEMOSTASIS INTRODUCER | St Jude Medical | 2014-03-11 | Special | PDF ↗ |
| K131627 | CATHETER INTRODUCER SHEATH | Edwards Lifesciences, LLC | 2014-03-06 | Traditional | PDF ↗ |
| K133296 | XCATH | Alseal | 2014-02-14 | Traditional | PDF ↗ |
| K130633 | INTRODUCER SETS, MODEL ADELANTE RADIAL | Oscor, Inc. | 2014-02-13 | Traditional | PDF ↗ |
| K132720 | HEARTSPAN FIXED CURVE BRAIDED TRANSSEPTAL SHEATH | Merit Medical Systems, Inc. | 2014-02-12 | Traditional | PDF ↗ |
| K140015 | CARDIOSOLUTIONS DEXTERITY STEERABLE INTRODUCER | Cardiosolutions, Inc. | 2014-02-05 | Special | PDF ↗ |
| K123475 | SHOOCIN INTRODUCER KIT | Lepu Medical Technology (Beijing) Co., Ltd. | 2014-02-03 | Traditional | PDF ↗ |
| K132498 | VALVED TEARAWAY INTRODUCER GENERATION II | Medcomp (Medical Components, Inc.) | 2013-11-25 | Special | PDF ↗ |
| K130730 | V-STICK VASCULAR ACCESS SET | Argon Medical | 2013-11-22 | Special | PDF ↗ |
| K132030 | MICRA INTRODUCER SHEATH WITH HYDROPHILIC COATING | Medtronic, Inc. | 2013-09-27 | Traditional | PDF ↗ |
| K132164 | HEARTSPAN STEERABLE INTRODUCER KIT | Merit Medical Systems, Inc. | 2013-09-17 | Special | PDF ↗ |
| K131148 | THE CVC WAND SAFETY INTRODUCER WITH VALVED PEELABLE SHEATH | Access Scientific, LLC | 2013-09-04 | Traditional | PDF ↗ |
| K132263 | AXERA 2 ACCESS SYSTEM | Arstasis, Inc. | 2013-08-19 | Special | PDF ↗ |
| K130687 | 2F & 3F VASCU-SHEATH TEARAWAY INTRODUCER | Medical Components, Inc. | 2013-08-15 | Traditional | PDF ↗ |
| K131144 | AMECO SHEATH INTRODUCER | Ameco Medical Industries | 2013-08-15 | Traditional | PDF ↗ |
| K131079 | CREGANNA-TACTX STEERABLE SHEATH SET SYMMETRIC | Creganna Medical Devices | 2013-08-01 | Traditional | PDF ↗ |
| K130855 | PTFE SUPER SHEATH INTRODUCER | Martech Medical Products | 2013-07-29 | Traditional | PDF ↗ |
| K123714 | EDWARDS EMBOL-X INTRODUCER SHEATH | Edwards Lifesciences, LLC | 2013-07-24 | Traditional | PDF ↗ |
| K131332 | CARDIOSOLUTIONS PERCU-PRO STEERABLE INTRODUCER | Cardiosolutions, Inc. | 2013-07-19 | Special | PDF ↗ |
| K131300 | THE POWERWAND SAFETY INTRODUCER WITH AN EXTENDED DWELL CATHETER | Access Scientific, LLC | 2013-06-07 | Special | PDF ↗ |
| K124046 | VALVED TEARAWAY INTRODUCER GENERATION II | Medical Components, Inc. | 2013-06-03 | Traditional | PDF ↗ |
| K130559 | MOBICATH BI-DIRECTIONAL GUIDING SHEATH | Great Batch Medical | 2013-05-24 | Special | PDF ↗ |
| K121404 | SOLOPATH RE-COLLAPSIBLE ACCESS SYSTEM | Onset Medical Corporation | 2013-05-03 | Traditional | PDF ↗ |
| K123990 | SENTRANT INTRODUCER SHEATH WITH HYDROPHILIC COATING | Medtronic Vascular | 2013-04-26 | Traditional | PDF ↗ |
| K123430 | MICROSLIDER TEARAWAY INTRODUCER SET | Galt Medical Corp. | 2013-04-12 | Traditional | PDF ↗ |
| K123618 | AXERA 2 ACCESS SYSTEM | Arstasis, Inc. | 2013-03-24 | Traditional | PDF ↗ |
| K123974 | PERCUTANEOUS INTRODUCER KIT | Teleflex, Inc. | 2013-02-21 | Traditional | PDF ↗ |
| K123235 | EQUAFLOW MULTIVALVE INFUSION CATHETER | Cook Incorporated | 2013-02-14 | Traditional | PDF ↗ |
| K122431 | HEARTSPAN STEERABLE INTRODUCER KIT | Thomas Medical Products, Inc. | 2013-01-29 | Traditional | PDF ↗ |
| K123135 | AXERA 2 ACCESS SYSTEM MODEL AXE200 | Arstasis, Inc. | 2013-01-28 | Traditional | PDF ↗ |
| K122926 | SUREFLEX STEERABLE GUIDING SHEATH KIT | Baylis Medical Co., Inc. | 2013-01-24 | Traditional | PDF ↗ |
| K123334 | REPROCESSED STEERABLE INTRODUCER | Stryker Sustainability Solutions, Inc. | 2013-01-24 | Traditional | PDF ↗ |
| K122854 | ARROW GLIDETHRU PEEL-AWAY SHEATH/DILATOR INTRODUCER | Arrow International (Subsidiary of Teleflex Inc.) | 2013-01-04 | Traditional | PDF ↗ |
| K122958 | DELIVERY SHEATH, MODEL ADELANTE BREEZEWAY | Oscor, Inc. | 2012-12-13 | Traditional | PDF ↗ |
| K122960 | STEERABLE GUIDING SHEATH, MODEL ADELANTE DESTINO | Oscor, Inc. | 2012-12-13 | Traditional | PDF ↗ |
| K122980 | GLIDESHEATH SLENDER MODEL RM* ES6J10HQS, GLIDESHEATH SLENDER MODEL RM* ES6F16HQ, GLIDESHEATH SLENDER MODEL RM * RS6J10PQ | Terumo Medical Corporation | 2012-12-11 | Traditional | PDF ↗ |
| K121234 | GORE(R) DRYSEAL SHEATH WITH HYDROPHILIC COATING | W. L. Gore & Associates, Inc. | 2012-11-20 | Traditional | PDF ↗ |
| K120617 | PTFE SUPER SHEATH INTRODUCER | Martech Medical Products | 2012-11-19 | Traditional | PDF ↗ |
| K121504 | SUPER SHEATH INTRODUCER SHEATH AND SUPER SHEATH INTRODUCER SHEATH SETS | Togo Medikit Co., Ltd. | 2012-09-27 | Traditional | PDF ↗ |
| K122084 | INTRODUCER SET, MODEL ADELANTE-S SERIES | Oscor, Inc. | 2012-08-29 | Special | PDF ↗ |
| K111603 | LINEBACKER(TM) TRANSSEPTAL INTRODUCER, 53CM / 62CM / 72CM | Ep Dynamics, Inc. | 2012-08-23 | Traditional | PDF ↗ |
| K121185 | EDWARDS PERCUTANEOUS SHEATH INTRODUCER | Edwards Lifesciences, LLC | 2012-08-22 | Traditional | PDF ↗ |
| K122190 | PRELUDE 7F SHORT SHEATH INTRODUCER | Merit Medical Systems, Inc. | 2012-08-17 | Special | PDF ↗ |
| K120158 | CORONARY SINUS GUIDE AND LATERAL VEIN INTRODUCER KITS | Thomas Medical Products, Inc. | 2012-08-14 | Traditional | PDF ↗ |
| K113849 | HQS INTRODUCER | Alseal | 2012-07-31 | Traditional | PDF ↗ |
| K121748 | THE POWERWAND SAFETY INTRODUCER WITH AND EXTENDED DWELL | Access Scientific, Inc. | 2012-07-27 | Special | PDF ↗ |
| K120459 | STEERABLE GUIDING SHEATH, MODEL ADELANTE DESTINO | Oscor, Inc. | 2012-06-29 | Traditional | PDF ↗ |
| K121521 | AXERA ACCESS SYSTEM | Arstasis, Inc. | 2012-06-21 | Special | PDF ↗ |
| K120428 | GORE DRYSEAL SHEATH | W. L. Gore & Associates, Inc. | 2012-04-20 | Special | PDF ↗ |
| K112398 | TRIV(TM) VALVED TEARAWAY INTRODUCER, TIRV(TM) VALVED TEARAWAY INTRODUCER WITH SIDE PORT | Galt Medical | 2012-04-12 | Special | PDF ↗ |
| K112887 | UPSTREAM NEEDLE HOLDER, UPSTREAM NEEDLE HOLDER WITH SHUT-OFF CONNECTOR | Upstream Peripheral Technologies | 2012-03-21 | Traditional | PDF ↗ |
| K112407 | SMITH MEDICAL PEEL-AWAY SHEATH INTRODUCERS | Smiths Medical MD, Inc. | 2012-02-09 | Traditional | PDF ↗ |
| K120212 | AFX INTRODUCER SYSTEM | Endologix, Inc. | 2012-02-09 | Special | PDF ↗ |
| K113196 | VASCULAR SONO | PAJUNK GmbH Medizintechnologie | 2012-02-06 | Traditional | PDF ↗ |
| K110051 | RADIALSOURCE TRANSRADIAL ACCESS INTRODUCER KIT | Great Batch Medical | 2012-02-02 | Traditional | PDF ↗ |
| K112554 | TRANSRADIAL ARTERY ACCESS DEVICES | Teleflexmedical, Inc. | 2011-11-18 | Traditional | PDF ↗ |
| K102925 | NEXGEN EXPANDABLE CATHETER | Nexgen Medical Systems, Inc. | 2011-11-10 | Traditional | PDF ↗ |
| K113110 | AXERA ACCESS SYSTEM | Arstasis, Inc. | 2011-11-09 | Special | PDF ↗ |
| K111606 | PINNACLE PRECISION ACCESS SYSTEM | Terumo Medical Corp. | 2011-10-03 | Traditional | PDF ↗ |
| K111943 | AGILLS PF DELIVERY SYSTEM | St. Jude Medical, Cardiac Rhythm Management Divisi | 2011-09-29 | Traditional | PDF ↗ |
| K111417 | THE POWERWAND (R) SAFETY INTRODUCER WITH AN EXTENDED DWELL CATHETER | Access Scientific, Inc. | 2011-07-15 | Special | PDF ↗ |
| K111747 | ENDOLOGIX AFX INTRODUCER SYSTEM | Endologix, Inc. | 2011-07-12 | Special | PDF ↗ |
| K111138 | THE PICC WAND (R) PEELABLE SAFETY INTRODUCER | Access Scientific, Inc. | 2011-06-22 | Special | PDF ↗ |
| K111092 | ENGAGE/ENGAGE TR INTRODUCERS | St Jude Medical | 2011-06-09 | Special | PDF ↗ |
| K110090 | AFX INTRODUCER SYSTEM | Endologix, Inc. | 2011-05-26 | Traditional | PDF ↗ |
| K110450 | AGILIS NXT STEERABLE INTRODUCER | St Jude Medical | 2011-05-10 | Traditional | PDF ↗ |
| K103083 | AGILIS ES STEERABLE INTRODUCER | St Jude Medical | 2011-04-08 | Traditional | PDF ↗ |
| K102948 | TORFLEX TRANSSEPTAL GUIDING SHEATH | Baylis Medical Co., Inc. | 2011-04-01 | Traditional | PDF ↗ |
| K101422 | THE POWER WAND SAFETY INTRODUCER WITH AN EXTENDED DWELL CATHETER | Access Scientific, Inc. | 2011-03-22 | Traditional | PDF ↗ |
| K100799 | FORTRESS INTRODUCER SHEATH SYSTEM MODEL 358813, 358814, 358815 | Contract Medical Intl. GmbH | 2011-02-25 | Traditional | PDF ↗ |
| K103143 | ARSTASIS ONE LATCHWIRE ACCESS SYSTEM | Arstasis, Inc. | 2011-02-02 | Special | PDF ↗ |
| K101604 | VSI MICRO-INTRODUCER SETS (REGULAR, STIFFEN), MODELS 7197V-7209V, 7240V-7256V, 7259V, 7230V, 7231V, 7260V, 7274V | Vascular Solutions, Inc. | 2011-01-24 | Traditional | PDF ↗ |
| K101784 | MOBICATH BI-DIRECTIONAL GUIDING SHEATH MODEL 1000182-XXX | Great Batch Medical | 2010-11-26 | Traditional | PDF ↗ |
| K102540 | PTFE PORTABLE INTRODUCER | Great Batch Medical | 2010-11-16 | Special | PDF ↗ |
| K101497 | DELIVERY SHEATH, MODEL ADELANTE BREEZEWAY | Oscor, Inc. | 2010-10-20 | Traditional | PDF ↗ |
| K102728 | ARSTASIS ACCESS SYSTEM | Arstasis, Inc. | 2010-10-07 | Special | PDF ↗ |
| K101883 | 6F ENGAGE/ENGAGE TR INTRODUCER | St Jude Medical | 2010-09-07 | Special | PDF ↗ |
| K101150 | PICC WAND PEELABLE SAFETY INTRODUCER | Access Scientific, Inc. | 2010-08-13 | Special | PDF ↗ |
| K100819 | THE SOLOPATH BALLOON EXPANDABLE TRANSFEMORAL INTRODUCER | Onset Medical Corporation | 2010-08-02 | Special | PDF ↗ |
| K102008 | GLIDESHEATH | Terumo Medical Corp. | 2010-07-21 | Traditional | PDF ↗ |
| K093877 | RETROFLEX 3 INTRODUCER SHEATH SET, MODELS 9120S23 AND 9120S26 | Edwards Lifesciences, LLC | 2010-07-01 | Traditional | PDF ↗ |
Product code DYB · Class II · Cardiovascular. Data: openFDA.