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 |
|---|---|---|---|
| Jul 15, 2003 | K030135 | SAFETY INTRODUCER NEEDLE B.Braun Medical, Inc. | DYB |
| Jun 20, 2003 | K030944 | EDWARDS LIFESCIENCES PERCUTANEOUS SHEATH INTRODUCERS WITH OLIGON MATERIAL Edwards Lifesciences, LLC | DYB |
| Jun 16, 2003 | K031583 | MODIFICATION TO IVS INTRODUCER SET, MODEL 1003 Integrated Vascular Systems, Inc. | DYB |
| May 27, 2003 | K023937 | COOK VASCULAR SERPENTA CORONARY SINUS INTRODUCER SYSTEM Cook Vascular, Inc. | DYB |
| Apr 24, 2003 | K031087 | EDWARDS INTRODUCER SHEATH Edwards Lifesciences, LLC | DYB |
| Apr 9, 2003 | K030905 | MEDAMICUS FLOWGUARD PEELABLE INTRODUCER Medamicus, Inc. | DYB |
| Apr 3, 2003 | K030723 | IVS INTRODUCER SET, MODEL 1003 Integrated Vascular Systems, Inc. | DYB |
| Jan 21, 2003 | K022170 | INNER-LOCK LOCKING INTRODUCER SHEATHS Rex Medical | DYB |
| Nov 6, 2002 | K022634 | CO-AXIAL INTRODUCER NEEDLE Promex, Inc. | DYB |
| Oct 31, 2002 | K023447 | MODIFICATION TO ULTIMUM EV HEMOSTASIS INTRODUCER (22F) St Jude Medical | DYB |
| Oct 25, 2002 | K022513 | MEDCOMP VASCU-SHEATH INTRODUCER SET Medcomp | DYB |
| Oct 11, 2002 | K020964 | NEICH NM ADVANCE CATHETER SHEATH INTRODUCER Neich Medical(Shenzhen)Company, Ltd., CN | DYB |
| Sep 13, 2002 | K022003 | TITAN MICRO CATHETER, MODEL 105-5074-153; HD INJECTOR, MODEL 103-0305 Micro Therapeutics, Inc. | DYB |
| Aug 23, 2002 | K022689 | MODIFICATION TO MEDAMICUS AXIA RSN Medamicus, Inc. | DYB |
| Aug 8, 2002 | K021723 | SHEATH ADAPTER, MODEL SA-09847 Arrow Intl., Inc. | DYB |
| Jul 3, 2002 | K021094 | INTROCAN SAFETY IV CATHETER B.Braun Medical, Inc. | DYB |
| Jun 12, 2002 | K020834 | BD INTROSYTE PRECISION INTRODUCER; BD INTROSYTE-N PRECISION INTRODUCER; BD INTROSYTE AUTOGUARD SHIELDED INTRODUCER; BD I Becton Dickinson Infusion Therapy Systems, Inc. | DYB |
| Jun 6, 2002 | K021004 | VALVED PEELABLE INTRODUCER Medamicus, Inc. | DYB |
| May 21, 2002 | K020563 | MEDAMICUS AXIA RSN Medamicus, Inc. | DYB |
| Apr 25, 2002 | K010128 | COOK VASCULAR PEEL-AWAY HEMOSTASIS VALVE Cook Vascular, Inc. | DYB |
| Mar 8, 2002 | K014052 | EDWARDS LIFESCIENCES PERCUTANEOUS SHEATH INTRODUCERS WITH OLIGON MATERIAL Edwards Lifesciences, LLC | DYB |
| Feb 11, 2002 | K020090 | MODIFICATION TO TRANSSEPTAL INTRODUCER SET Thomas Medical Products, Inc. | DYB |
| Jan 24, 2002 | K003889 | ANCURE SHEATH MODEL # 40315, 40320, 40325 Guidant Cardiac and Vascular Surgery | DYB |
| Nov 21, 2001 | K012854 | RENAL GUIDING SHEATH Terumo Medical Corp. | DYB |
| Nov 14, 2001 | K012812 | CAROTID GUIDING SHEATH Terumo Medical Corp. | DYB |
| Oct 31, 2001 | K011761 | MAC TWO-LUMEN CENTRAL VENOUS KIT WITH ARROWG ARD BLUE ANTIMICROBIAL SURFACE AND INTEGRAL HEMOSTASIS VALVE/SIDE PORT Arrow Intl., Inc. | DYB |
| Oct 23, 2001 | K013202 | MODIFICATION TO BRAIDED GUIDING INTRODUCER Thomas Medical Products, Inc. | DYB |
| Oct 9, 2001 | K013029 | SEAL-AWAY CS INTRODUCER KIT, MODELS 407514, 407515 St Jude Medical | DYB |
| Sep 28, 2001 | K010913 | VYGON SPLIT CANNULA INTRODUCER Vygon Corp. | DYB |
| Sep 25, 2001 | K012922 | ULTRAFLEX EV HEMOSTASIS INTRODUCER St Jude Medical | DYB |
| Sep 5, 2001 | K011790 | MICROCRUISER PLUS INTRODUCER SET Medical Device Technologies, Inc. | DYB |
| Aug 30, 2001 | K012489 | MODIFICATION TO: X-SEPT TRANSSEPTAL SHEALTH AND TRANSITION CATHETER (WITH DILATOR), MODELS PL-12-12-09, PL-12-12-10 Appriva Medical, Inc. | DYB |
| Jul 19, 2001 | K004025 | SPLITTABLE SHEATH INTRODUCER KIT Thomas Medical Products, Inc. | DYB |
| Jul 9, 2001 | K011085 | GUIDEWIRE INTRODUCER SAFETY NEEDLE Medamicus, Inc. | DYB |
| Jul 9, 2001 | K004026 | BRAIDED GUIDING INTRODUCER Thomas Medical Products, Inc. | DYB |
| May 31, 2001 | K002847 | INTRODUCER WITH DISTAL RADIOPAQUE MARKER BAND, MODEL OR-4926XX Maxxim Medical | DYB |
| Apr 26, 2001 | K002973 | EMBOL-X INTRODUCER, MODEL CF00200 Embol-X, Inc. | DYB |
| Apr 10, 2001 | K003731 | SAFESHEATH MSP INTRODUCER SHEATH KIT WITH INTEGRAL HEMOSTASIS VALVE Thomas Medical Products, Inc. | DYB |
| Mar 21, 2001 | K002507 | TWO-LUMEN CENTRAL VENOUS ACCESS KIT WITH HEMOSTASIS VALVE/SIDE PORT Arrow Intl., Inc. | DYB |
| Feb 16, 2001 | K002054 | X-SEPT TRANSSEPTAL SHEATH AND TRANSITION CATHETER, MODEL MV-03-09-90, MV-03-10-90, MV-03-11-90, MV-03-09-120, MV-03-10-1 Appriva Medical, Inc. | DYB |
| Jan 25, 2001 | K001985 | INTRODEUCE DOUBLE LUMEN INTRODUCER Cook, Inc. | DYB |
| Jan 3, 2001 | K003729 | ULTIMUM EV HEMOSTASIS INTRODUCER (14F), ULTIMUM EV HEMOSTASIS INTRODUCER (16F), ULTIMUM EV HEMOSTASIS INTRODUCER (18F), St Jude Medical | DYB |
| Nov 29, 2000 | K000004 | ALLIANCE LEFT HEART DELIVERY SYSTEM INTRODUCER, MODEL #407509 Daig Corp. | DYB |
| Nov 21, 2000 | K003424 | PINNACLE R/O II OR RADIFOCUS INTRODUCER II Terumo Medical Corp. | DYB |
| Oct 30, 2000 | K002676 | ENDOVANCE DUALPASS TEAR-AWAY SHEATH INTRODUCER Guidant Cardiac and Vascular Surgery | DYB |
| Sep 22, 2000 | K001926 | VASCULAR GRAFT TUNNELER-STANDARD CURVE, MID CURVE, FULL CURVE, SHORT STANDARD CURVE, VASCULAR GRAFT TUNNELER ACCESSORIES Thoratec Laboratories Corp. | DYB |
| Aug 25, 2000 | K002365 | DATASCOPE REINFORCED PERCUTANEOUS CATHETER INTRODUCER SET Datascope Corp. | DYB |
| Jul 3, 2000 | K001135 | 6F & 7F INTRODUCING CATHETERS (MODIFICATION) Cordis Corp. | DYB |
| Jun 16, 2000 | K000313 | TEARAWAY INTRODUCER SHEATH Xentek Medical, Inc. | DYB |
| May 31, 2000 | K001367 | FAST-CATH 18F HEMOSTASIS INTRODUCER, MODEL 406XXX St. Jude Medical, Inc. | DYB |
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