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 |
|---|---|---|---|
| May 26, 2000 | K992668 | INNERDYNE RADIALLY EXPANDING VASCULAR ACCESS SYSTEM (REVAS) Innerdyne, Inc. | DYB |
| May 24, 2000 | K001346 | ULTIMUM HEMOSTASIS INTRODUCER, MODEL 4076XX St. Jude Medical, Inc. | DYB |
| May 15, 2000 | K994334 | ULTRA-FLEX HEMOSTASIS INTRODUCER. MODEL 406XXX Daig Corp. | DYB |
| May 10, 2000 | K001139 | PREFACE GUIDING SHEATH, MODELS 2-603M, 2-703M, 2-803M, 2-903M, 2-1003M, 2-1103M Biosense Webster, Inc. | DYB |
| Apr 13, 2000 | K000824 | PERCUTANEOUS INTRODUCER, MODEL 10383-XXX Medamicus, Inc. | DYB |
| Mar 24, 2000 | K993191 | TFX MEDICAL INTRODUCER ASSEMBLY Tfx Medical, Inc. | DYB |
| Mar 15, 2000 | K990975 | IN-LINE HEMOSTASIS VALVE Merit Medical Systems, Inc. | DYB |
| Jan 4, 2000 | K994252 | INTRODUCER SHEATHS, VESSEL DILATOR, GUIDEWIRE Boston Scientific Corp | DYB |
| Jan 4, 2000 | K991647 | TFX MEDICAL INTRODUCER KIT Tfx Medical Group | DYB |
| Oct 7, 1999 | K992309 | INTRODUCER SHEATH, VESSEL DILATOR Boston Scientific Corp | DYB |
| Jul 15, 1999 | K983940 | EZ-INTRO PERCUTANEOUS CATHETER SHEATH, EZ-INTRO VESSEL DILATOR Adam Spence Corp. | DYB |
| Jun 28, 1999 | K990705 | MEDAMICUS COAXIAL INTRODUCER KIT, 10330-XXX, BOSTON SCIENTIFIC COAXIAL DILATOR SET Medamicus, Inc. | DYB |
| May 7, 1999 | K983039 | EMCEE INFUSION INTRODUCER SHEATH, EMCEE INFUSION INTRODUCER SET DILATOR, EMCEE INFUSION INTRODUCER SHEATH SET, EMCEE INF Schneider/Namic | DYB |
| Mar 24, 1999 | K984062 | SEAL-AWAY HEMOSTASIS ADAPTER, MODEL 406229 Diag Corp. | DYB |
| Jan 26, 1999 | K984260 | PINNACLE R/O OR REDIFOCUS INTRODUCER R/O (COMPRISED OF A SHEATH & DILATOR) Terumo Medical Corp. | DYB |
| Dec 23, 1998 | K984500 | CORDIS BRITE TIP CATHETER SHEATH INTRODUCER SYSTEM Cordis Corp. | DYB |
| Nov 30, 1998 | K982797 | BLUNT T-PEEL INTRODUCER MODEL NUMBER PE-16PICB, PE-18PICB, PE-20PICB, PE-24PICB Luther Medical Products, Inc. | DYB |
| Nov 24, 1998 | K981909 | BAXTER HEMOSTASIS VALVE INTRODUCERS Baxter Edwards | DYB |
| Oct 1, 1998 | K983023 | MODIFICATION TO CORDIS BRITE TIP CATHETER SHEATH INTRODUCER SYSTEM Cordis Corp. | DYB |
| Sep 16, 1998 | K982187 | FAST-CATH INTRA-CARDIAC INTRODUCER Daig Corp. | DYB |
| Sep 11, 1998 | K980578 | INNERDYNE RADIALLY EXPANDING VASCULAR ACCESS SYSTEM (HEPARIN COATED) Innerdyne, Inc. | DYB |
| Aug 28, 1998 | K982740 | CORDIS WEBSTER PREFACE BRAIDED GUIDING SHEATH & PERRY EXCHANGE DILATOR, MODEL #'S 301-803A, 301-803P, 301-803M, 301-813S Cordis Webster, Inc. | DYB |
| Aug 12, 1998 | K981782 | LOW PROFILE PORT ATTACHABLE CATHETER WITH BLUE FLEX TIP / 8FR. INRODUCER KIT IMPLANTABLE VASCULAR ACCESS SYSTEM Arrow Intl., Inc. | DYB |
| Aug 7, 1998 | K980504 | EMCEE INTRODUCER SHEATH, DILATOR, OBTURATOR, INTRODUCER SET Schneider/Namic | DYB |
| May 21, 1998 | K973840 | FAST-CATH (TM) INTRA-CARDIAC INTRODUCER Daig Corp. | DYB |
| Feb 13, 1998 | K970229 | ARROW TRANSSEPTAL SUPER ARROW-FLEX PERCUTANEOUS SET Arrow Intl., Inc. | DYB |
| Feb 6, 1998 | K974448 | CORDIS BRITE TIP CATHETER SHEATH INTRODUCER SYSTEM Cordis Corp. | DYB |
| Nov 6, 1997 | K973007 | DATASCOPE'S 10 FR. FLEXISHEATH PERCUTANEOUS INTRODUCER Datascope Corp. | DYB |
| Oct 28, 1997 | K970264 | CORDIS WEBSTER BRAIDED GUIDING SHEATH EXCHANGE SYSTEM Cordis Webster, Inc. | DYB |
| Oct 10, 1997 | K972684 | INNERDYNE RADIALLY EXPANDING VASCULAR ACCESS SYSTEM Innerdyne, Inc. | DYB |
| Oct 1, 1997 | K972570 | HEARTPORT INTRODUCER SHEATH Heartport, Inc. | DYB |
| Jul 25, 1997 | K965167 | PERCUTANEOUS VENOUS INTRODUCER 10264 Medamicus, Inc. | DYB |
| Jul 21, 1997 | K971608 | CORDIS BRITE TIP CATHETER SHEATH INTRODUCER SYSTEM Cordis Corp. | DYB |
| May 14, 1997 | K964518 | FAST-CATH TRANSSEPTAL CATHETER INTRODUCER Daig Corp. | DYB |
| May 7, 1997 | K964814 | BIPORE ACCUFLEX PERCUTANEOUS SHEATH INTRODUCER Bipore, Inc. | DYB |
| May 6, 1997 | K964034 | TRANSJUGULAR ACCESS SET AngioDynamics, Inc. | DYB |
| Apr 24, 1997 | K963886 | EVS Applied Medical Resources | DYB |
| Apr 21, 1997 | K970201 | GSI CANNULA WITH INTRODUCER General Surgical Innovations | DYB |
| Jan 7, 1997 | K962978 | CCENTERMARK CATHETER INTRODUCER SHEALTH WITH PROTECTIV 2000 NEEDLE SAFETY SYSTEM Johnson & Johnson Medical, Inc. | DYB |
| Dec 24, 1996 | K961780 | HEMODIALYSIS INTRODUCER SET Thomas Medical Products, Inc. | DYB |
| Nov 7, 1996 | K962180 | CATH SEAL Universal Medical Instrument Corp. | DYB |
| Oct 11, 1996 | K962746 | CORDIS AVANTI TRANS-RADIAL CATHETER SHEATH INTRODUCER KIT Cordis Corp. | DYB |
| Sep 17, 1996 | K961745 | BRAUN PERCUTANEOUS INTRODUCER SET B.Braun Medical, Inc. | DYB |
| Sep 12, 1996 | K961466 | PERCUTANEOUS INTRODUCER SET Thomas Medical Products, Inc. | DYB |
| Aug 12, 1996 | K960445 | INPUT TUOHY-BORST LOCKING DEVICE C.R. Bard, Inc. | DYB |
| Aug 8, 1996 | K960625 | SPREADABLE SHEATH INTRODUCER SET Neostar Medical Technologies, Inc. | DYB |
| Jul 2, 1996 | K960200 | INTROSTAT LEAD INTRODUCER Msi, Inc. | DYB |
| May 13, 1996 | K961513 | PROCATH LOCKING PEEL-AWAY INTRODUCER/PEEL-AWAY INTRODUCER SET Ep Medsystems | DYB |
| Apr 30, 1996 | K961135 | INPUT 10F/11/F INTRODUCER SET(010101(10F), 011101(11F) C.R. Bard, Inc. | DYB |
| Apr 12, 1996 | K960406 | BRAUN HEMOSTASIS INTRODUCERS B.Braun Medical, Inc. | DYB |
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