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 |
|---|---|---|---|
| Nov 21, 2014 | K142183 | GLIDESHEATH SLENDER Terumo Medical Corporation | DYB |
| Nov 6, 2014 | K142684 | FlexCath Select Steerable Sheath (10 French) Medtronic Cryocath, LP | DYB |
| Oct 29, 2014 | K142245 | EpiAccess System Epiep, Inc. | DYB |
| Oct 16, 2014 | K140543 | PRELUDEEASE HYDROPHILIC SHEATH INTRODUCER Merit Medical Systems, Inc. | DYB |
| Oct 9, 2014 | K132592 | FLEXOR RADIAL HYDROPHILIC INTRODUCER ACCESS SET Cook, Inc. | DYB |
| Sep 18, 2014 | K141696 | EDWARDS ESHEATH INTRODUCER SET Edwards Lifesciences | DYB |
| Aug 27, 2014 | K140338 | CREGANNA TACTX LOTUS INTRODUCER SET (SMALL), CREGANNA TACTX LOTUS INTRODUCER SET (LARGE) Creganna-Tactx Medical, IE | DYB |
| Aug 21, 2014 | K140028 | GALT VTI LOW INSERTION VALVE TEARAWAY INTRODUCER Galt Medical Corp. | DYB |
| Jul 9, 2014 | K140917 | INTRODUCER, MODEL ADELANTE MAGNUM Oscor, Inc. | DYB |
| Jul 9, 2014 | K140513 | MERIT SAFETY INTRODUCER NEEDLE Merit Medical Systems, Inc. | DYB |
| Jul 3, 2014 | K140641 | VESSIX GUIDE SHEATH 7F, 45 CM, RDC, VESSIX GUIDE SHEATH 7F, 45CM, LIMA Boston Scientific Corporation | DYB |
| Jul 3, 2014 | K133114 | MICROPUNCTURE INTRODUCER SET Cook Incorporated | DYB |
| Jun 6, 2014 | K140871 | AXERA 2 ACCESS SYSTEM Arstasis, Inc. | DYB |
| May 16, 2014 | K140287 | AXERA RX ACCESS SYSTEM Arstasis, Inc. | DYB |
| Apr 30, 2014 | K132617 | MEDTRONIC INPUT PS INTRODUCER Medtronic, Inc. | DYB |
| Apr 17, 2014 | K140406 | DESTINO TWIST, STEERABLE GUIDING SHEATH Oscor, Inc. | DYB |
| Apr 17, 2014 | K132789 | FLIP INTRODUCER ACCESS KIT Vascular Solutions, Inc. | DYB |
| Apr 1, 2014 | K140420 | VADO STEERABLE SHEATH Kalila Medical, Inc. | DYB |
| Mar 28, 2014 | K140201 | AXERA 2 ACCESS SYSTEM Arstasis, Inc. | DYB |
| Mar 19, 2014 | K140398 | EMBOL-X INTRODUCER SHEATH Edwards Lifesciences, LLC | DYB |
| Mar 11, 2014 | K140327 | ULTIMUM EV HEMOSTASIS INTRODUCER St Jude Medical | DYB |
| Mar 6, 2014 | K131627 | CATHETER INTRODUCER SHEATH Edwards Lifesciences, LLC | DYB |
| Feb 14, 2014 | K133296 | XCATH Alseal | DYB |
| Feb 13, 2014 | K130633 | INTRODUCER SETS, MODEL ADELANTE RADIAL Oscor, Inc. | DYB |
| Feb 12, 2014 | K132720 | HEARTSPAN FIXED CURVE BRAIDED TRANSSEPTAL SHEATH Merit Medical Systems, Inc. | DYB |
| Feb 5, 2014 | K140015 | CARDIOSOLUTIONS DEXTERITY STEERABLE INTRODUCER Cardiosolutions, Inc. | DYB |
| Feb 3, 2014 | K123475 | SHOOCIN INTRODUCER KIT Lepu Medical Technology (Beijing) Co., Ltd. | DYB |
| Nov 25, 2013 | K132498 | VALVED TEARAWAY INTRODUCER GENERATION II Medcomp (Medical Components, Inc.) | DYB |
| Nov 22, 2013 | K130730 | V-STICK VASCULAR ACCESS SET Argon Medical | DYB |
| Sep 27, 2013 | K132030 | MICRA INTRODUCER SHEATH WITH HYDROPHILIC COATING Medtronic, Inc. | DYB |
| Sep 17, 2013 | K132164 | HEARTSPAN STEERABLE INTRODUCER KIT Merit Medical Systems, Inc. | DYB |
| Sep 4, 2013 | K131148 | THE CVC WAND SAFETY INTRODUCER WITH VALVED PEELABLE SHEATH Access Scientific, LLC | DYB |
| Aug 19, 2013 | K132263 | AXERA 2 ACCESS SYSTEM Arstasis, Inc. | DYB |
| Aug 15, 2013 | K131144 | AMECO SHEATH INTRODUCER Ameco Medical Industries | DYB |
| Aug 15, 2013 | K130687 | 2F & 3F VASCU-SHEATH TEARAWAY INTRODUCER Medical Components, Inc. | DYB |
| Aug 1, 2013 | K131079 | CREGANNA-TACTX STEERABLE SHEATH SET SYMMETRIC Creganna Medical Devices | DYB |
| Jul 29, 2013 | K130855 | PTFE SUPER SHEATH INTRODUCER Martech Medical Products | DYB |
| Jul 24, 2013 | K123714 | EDWARDS EMBOL-X INTRODUCER SHEATH Edwards Lifesciences, LLC | DYB |
| Jul 19, 2013 | K131332 | CARDIOSOLUTIONS PERCU-PRO STEERABLE INTRODUCER Cardiosolutions, Inc. | DYB |
| Jun 7, 2013 | K131300 | THE POWERWAND SAFETY INTRODUCER WITH AN EXTENDED DWELL CATHETER Access Scientific, LLC | DYB |
| Jun 3, 2013 | K124046 | VALVED TEARAWAY INTRODUCER GENERATION II Medical Components, Inc. | DYB |
| May 24, 2013 | K130559 | MOBICATH BI-DIRECTIONAL GUIDING SHEATH Great Batch Medical | DYB |
| May 3, 2013 | K121404 | SOLOPATH RE-COLLAPSIBLE ACCESS SYSTEM Onset Medical Corporation | DYB |
| Apr 26, 2013 | K123990 | SENTRANT INTRODUCER SHEATH WITH HYDROPHILIC COATING Medtronic Vascular | DYB |
| Apr 12, 2013 | K123430 | MICROSLIDER TEARAWAY INTRODUCER SET Galt Medical Corp. | DYB |
| Mar 24, 2013 | K123618 | AXERA 2 ACCESS SYSTEM Arstasis, Inc. | DYB |
| Feb 21, 2013 | K123974 | PERCUTANEOUS INTRODUCER KIT Teleflex, Inc. | DYB |
| Feb 14, 2013 | K123235 | EQUAFLOW MULTIVALVE INFUSION CATHETER Cook Incorporated | DYB |
| Jan 29, 2013 | K122431 | HEARTSPAN STEERABLE INTRODUCER KIT Thomas Medical Products, Inc. | DYB |
| Jan 28, 2013 | K123135 | AXERA 2 ACCESS SYSTEM MODEL AXE200 Arstasis, Inc. | DYB |
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