Panels › Cardiovascular › Product code DYB · Class 2
Introducer, Catheter
Regulation 870.1340
19510(k)s in 12 months (707 all time)
27recalls in 12 months (389 all time)
337recalls that name a 510(k)
Top companies in DYB
| Company | 510(k)s | Recalls |
|---|---|---|
| Cook Incorporated | 20 | 67 |
| Terumo Medical Corp. | 27 | 29 |
| Merit Medical Systems | 19 | 35 |
| Oscor, Inc. | 13 | 37 |
| ARROW INTERNATIONAL, LLC | 0 | 37 |
| Abiomed, Inc. | 6 | 28 |
| Thomas Medical Products, Inc. | 17 | 15 |
| St Jude Medical | 26 | 3 |
| Cordis Corp. | 22 | 3 |
| Boston Scientific | 16 | 6 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 24, 2013 | K123334 | REPROCESSED STEERABLE INTRODUCER Stryker Sustainability Solutions, Inc. | DYB |
| Jan 24, 2013 | K122926 | SUREFLEX STEERABLE GUIDING SHEATH KIT Baylis Medical Co., Inc., CA | DYB |
| Jan 4, 2013 | K122854 | ARROW GLIDETHRU PEEL-AWAY SHEATH/DILATOR INTRODUCER Arrow International (Subsidiary of Teleflex Inc.) | DYB |
| Dec 13, 2012 | K122960 | STEERABLE GUIDING SHEATH, MODEL ADELANTE DESTINO Oscor, Inc. | DYB |
| Dec 13, 2012 | K122958 | DELIVERY SHEATH, MODEL ADELANTE BREEZEWAY Oscor, Inc. | DYB |
| Dec 11, 2012 | K122980 | GLIDESHEATH SLENDER MODEL RM* ES6J10HQS, GLIDESHEATH SLENDER MODEL RM* ES6F16HQ, GLIDESHEATH SLENDER MODEL RM * RS6J10PQ Terumo Medical Corporation | DYB |
| Nov 20, 2012 | K121234 | GORE(R) DRYSEAL SHEATH WITH HYDROPHILIC COATING W. L. Gore & Associates, Inc. | DYB |
| Nov 19, 2012 | K120617 | PTFE SUPER SHEATH INTRODUCER Martech Medical Products | DYB |
| Sep 27, 2012 | K121504 | SUPER SHEATH INTRODUCER SHEATH AND SUPER SHEATH INTRODUCER SHEATH SETS Togo Medikit Co., Ltd. | DYB |
| Aug 29, 2012 | K122084 | INTRODUCER SET, MODEL ADELANTE-S SERIES Oscor, Inc. | DYB |
| Aug 23, 2012 | K111603 | LINEBACKER(TM) TRANSSEPTAL INTRODUCER, 53CM / 62CM / 72CM Ep Dynamics, Inc. | DYB |
| Aug 22, 2012 | K121185 | EDWARDS PERCUTANEOUS SHEATH INTRODUCER Edwards Lifesciences, LLC | DYB |
| Aug 17, 2012 | K122190 | PRELUDE 7F SHORT SHEATH INTRODUCER Merit Medical Systems, Inc. | DYB |
| Aug 14, 2012 | K120158 | CORONARY SINUS GUIDE AND LATERAL VEIN INTRODUCER KITS Thomas Medical Products, Inc. | DYB |
| Jul 31, 2012 | K113849 | HQS INTRODUCER Alseal, FR | DYB |
| Jul 27, 2012 | K121748 | THE POWERWAND SAFETY INTRODUCER WITH AND EXTENDED DWELL Access Scientific, Inc. | DYB |
| Jun 29, 2012 | K120459 | STEERABLE GUIDING SHEATH, MODEL ADELANTE DESTINO Oscor, Inc. | DYB |
| Jun 21, 2012 | K121521 | AXERA ACCESS SYSTEM Arstasis, Inc. | DYB |
| Apr 20, 2012 | K120428 | GORE DRYSEAL SHEATH W. L. Gore & Associates, Inc. | DYB |
| Apr 12, 2012 | K112398 | TRIV(TM) VALVED TEARAWAY INTRODUCER, TIRV(TM) VALVED TEARAWAY INTRODUCER WITH SIDE PORT Galt Medical | DYB |
| Mar 21, 2012 | K112887 | UPSTREAM NEEDLE HOLDER, UPSTREAM NEEDLE HOLDER WITH SHUT-OFF CONNECTOR Upstream Peripheral Technologies | DYB |
| Feb 9, 2012 | K120212 | AFX INTRODUCER SYSTEM Endologix, Inc. | DYB |
| Feb 9, 2012 | K112407 | SMITH MEDICAL PEEL-AWAY SHEATH INTRODUCERS Smiths Medical MD, Inc. | DYB |
| Feb 6, 2012 | K113196 | VASCULAR SONO PAJUNK GmbH Medizintechnologie, DE | DYB |
| Feb 2, 2012 | K110051 | RADIALSOURCE TRANSRADIAL ACCESS INTRODUCER KIT Great Batch Medical | DYB |
| Nov 18, 2011 | K112554 | TRANSRADIAL ARTERY ACCESS DEVICES Teleflexmedical, Inc. | DYB |
| Nov 10, 2011 | K102925 | NEXGEN EXPANDABLE CATHETER Nexgen Medical Systems, Inc. | DYB |
| Nov 9, 2011 | K113110 | AXERA ACCESS SYSTEM Arstasis, Inc. | DYB |
| Oct 3, 2011 | K111606 | PINNACLE PRECISION ACCESS SYSTEM Terumo Medical Corp. | DYB |
| Sep 29, 2011 | K111943 | AGILLS PF DELIVERY SYSTEM St. Jude Medical, Cardiac Rhythm Management Divisi | DYB |
| Jul 15, 2011 | K111417 | THE POWERWAND (R) SAFETY INTRODUCER WITH AN EXTENDED DWELL CATHETER Access Scientific, Inc. | DYB |
| Jul 12, 2011 | K111747 | ENDOLOGIX AFX INTRODUCER SYSTEM Endologix, Inc. | DYB |
| Jun 22, 2011 | K111138 | THE PICC WAND (R) PEELABLE SAFETY INTRODUCER Access Scientific, Inc. | DYB |
| Jun 9, 2011 | K111092 | ENGAGE/ENGAGE TR INTRODUCERS St Jude Medical | DYB |
| May 26, 2011 | K110090 | AFX INTRODUCER SYSTEM Endologix, Inc. | DYB |
| May 10, 2011 | K110450 | AGILIS NXT STEERABLE INTRODUCER St Jude Medical | DYB |
| Apr 8, 2011 | K103083 | AGILIS ES STEERABLE INTRODUCER St Jude Medical | DYB |
| Apr 1, 2011 | K102948 | TORFLEX TRANSSEPTAL GUIDING SHEATH Baylis Medical Co., Inc., CA | DYB |
| Mar 22, 2011 | K101422 | THE POWER WAND SAFETY INTRODUCER WITH AN EXTENDED DWELL CATHETER Access Scientific, Inc. | DYB |
| Feb 25, 2011 | K100799 | FORTRESS INTRODUCER SHEATH SYSTEM MODEL 358813, 358814, 358815 Contract Medical Intl. GmbH, DE | DYB |
| Feb 2, 2011 | K103143 | ARSTASIS ONE LATCHWIRE ACCESS SYSTEM Arstasis, Inc. | DYB |
| Jan 24, 2011 | K101604 | VSI MICRO-INTRODUCER SETS (REGULAR, STIFFEN), MODELS 7197V-7209V, 7240V-7256V, 7259V, 7230V, 7231V, 7260V, 7274V Vascular Solutions, Inc. | DYB |
| Nov 26, 2010 | K101784 | MOBICATH BI-DIRECTIONAL GUIDING SHEATH MODEL 1000182-XXX Great Batch Medical | DYB |
| Nov 16, 2010 | K102540 | PTFE PORTABLE INTRODUCER Great Batch Medical | DYB |
| Oct 20, 2010 | K101497 | DELIVERY SHEATH, MODEL ADELANTE BREEZEWAY Oscor, Inc. | DYB |
| Oct 7, 2010 | K102728 | ARSTASIS ACCESS SYSTEM Arstasis, Inc. | DYB |
| Sep 7, 2010 | K101883 | 6F ENGAGE/ENGAGE TR INTRODUCER St Jude Medical | DYB |
| Aug 13, 2010 | K101150 | PICC WAND PEELABLE SAFETY INTRODUCER Access Scientific, Inc. | DYB |
| Aug 2, 2010 | K100819 | THE SOLOPATH BALLOON EXPANDABLE TRANSFEMORAL INTRODUCER Onset Medical Corporation | DYB |
| Jul 21, 2010 | K102008 | GLIDESHEATH Terumo Medical Corp. | DYB |
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