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 |
|---|---|---|---|
| Apr 8, 1996 | K954906 | FIRST PICC INTRODUCER CATHETER Becton Dickinson Vascular Access, Inc. | DYB |
| Mar 25, 1996 | K955820 | BRAUN HEMOSTASIS INTRODUCERS B.Braun Medical, Inc. | DYB |
| Mar 12, 1996 | K955785 | TS PERCUTANEOUS ARTERIAL/VENUS CATHETER INTRO SET C.R. Bard, Inc. | DYB |
| Feb 7, 1996 | K960310 | EPIC INTRODUCER SHEATH North American Instrument Corp. | DYB |
| Dec 28, 1995 | K954595 | CORDIS BRITE TIP SHEATH INTRODUCER Cordis Corp. | DYB |
| Dec 28, 1995 | K942977 | NOVOSTE PULSE PLUS BLOOD CONTAINMENT DEVICE Novoste Corp. | DYB |
| Nov 28, 1995 | K954317 | DIAG FAST-CATH DUO & TRIO REMOVABLE HEMOSTASIS ADAPTERS W/SIDEPORTS & 3-WAY STOPCOCKS Daig Corp. | DYB |
| Nov 27, 1995 | K954234 | RADIFOCUS INTRODUCER II KIT Terumo Medical Corp. | DYB |
| Aug 18, 1995 | K952828 | MEDI-TECH PERCUTANEOUS INTRODUCER SYSTEM Boston Scientific Corp | DYB |
| Aug 10, 1995 | K940092 | USCI INPUT INTRODUCER SET Usci, Div. C.R. Bard, Inc. | DYB |
| Aug 2, 1995 | K950155 | RAPID-TRAK(TM) INTRODUCER SHEATH Cardio Vascular Concepts, Inc. | DYB |
| Jun 27, 1995 | K951313 | MEDAMICUS PERCUTANEOUS INTRODUCER Medamicus, Inc. | DYB |
| Apr 26, 1995 | K945524 | CORDIS INTRODUCING CATHETER Cordis Corp. | DYB |
| Mar 29, 1995 | K945616 | CORDIS AVANTI CATHETER SHEATH INTRODUCER Cordis Corp. | DYB |
| Mar 13, 1995 | K945396 | FLUORO-TIP(R) HEMOSTASIS VALVE INTRODUCER SET B.Braun Medical, Inc. | DYB |
| Feb 21, 1995 | K933522 | INTRODUCER NEEDLE (SEVERAL SIZES) Mediziv Medical Products 1987 , Ltd., IL | DYB |
| Nov 30, 1994 | K940079 | ARROW PERCUTANEOUS SHEATH INTRODUCER KIT AK-07903 Arrow Intl., Inc. | DYB |
| Sep 21, 1994 | K942191 | URESIL DILATOR Uresil Corp. | DYB |
| Sep 14, 1994 | K944107 | VIP PLUS PERCUTANEOUS INTRODUCER Medamicus, Inc. | DYB |
| Jul 6, 1994 | K941428 | EXACTA PERCUTANEOUS INTRODUCER SHEATH Ohmeda Medical | DYB |
| Jun 7, 1994 | K935077 | CATH-SEAL Universal Medical Instrument Corp. | DYB |
| Apr 13, 1994 | K934624 | ACS ROTATING HEMOSTATIC VALVE & ACS DUOSTAT ROTATING HEMOSTATIC VALVE Advanced Cardiovascular Systems, Inc. | DYB |
| Mar 15, 1994 | K930808 | PROTECTOR INTRODUCER SHEATH Boston Scientific /International Technologies | DYB |
| Jan 21, 1994 | K934901 | TEAR-AWAY SHEATH INTRODUCER SET WITH INTEGRAL HEMOSTASIS VALVE Thomas Medical Products, Inc. | DYB |
| Nov 24, 1993 | K934285 | CATHETER INTRODUCER MODIFICATION Daig Corp. | DYB |
| Nov 9, 1993 | K932370 | REMINGTON MEDICAL DISPOS TEAR-AWAY VASC INTRO SET Remington Medical, Inc. | DYB |
| Nov 9, 1993 | K932323 | PERCUTANEOUS INTRODUCER Medamicus, Inc. | DYB |
| Nov 2, 1993 | K931743 | BURRON CARDIOVASCULAR ANGESTAT(TM) B.Braun Medical, Inc. | DYB |
| Oct 15, 1993 | K931489 | INTHERM RADIALLY EXPANDING DILATING INTRODUCER Innerdyne Medical, Inc. | DYB |
| Oct 6, 1993 | K931587 | MULTI-PORT Y INTRODUCER SET Thomas Medical Products, Inc. | DYB |
| Sep 22, 1993 | K931218 | INTROPEEL V Menlo Care, Inc. | DYB |
| Sep 22, 1993 | K930801 | INTROPEEL Menlo Care, Inc. | DYB |
| Sep 22, 1993 | K930194 | HEMOSTASIS VALVE AND TUBING SET Opticon Medical, Inc. | DYB |
| Aug 31, 1993 | K931662 | LEAD INTRODUCER SET, VARIOUS MODELS AND SIZES Pace Medical | DYB |
| Aug 26, 1993 | K932733 | CORDIS CATHETER SHEATH INTRODUCER Cordis Corp. | DYB |
| Aug 6, 1993 | K930057 | ANGESTAT FLUORO-TIP HEMOSTASIS INTRODUCER SET B.Braun Medical, Inc. | DYB |
| Jun 25, 1993 | K925633 | BALT INTRODUCER Target Therapeutics | DYB |
| May 27, 1993 | K931102 | CORDIS NIHON CATHETER SHEATH INTRODUCER Cordis Corp. | DYB |
| May 27, 1993 | K926340 | NEW LEAD INTRODUCER KITS, VARIOUS MODELS Telectronics Pacing Systems, Inc. | DYB |
| Apr 22, 1993 | K924607 | ARROW FISCHELL KINK RESIST PERCUT SHEATH INTRO SET Arrow Intl., Inc. | DYB |
| Mar 22, 1993 | K924456 | LONG LENGTH PERCUTANEOUS INTRODUCER SET Thomas Medical Products, Inc. | DYB |
| Mar 8, 1993 | K923603 | INTRA-AORTIC BALLOON PUMP CATHETER - MODIFICATION Kontron Instruments, Inc. | DYB |
| Feb 25, 1993 | K924562 | CATHETER INTRODUCER Luther Medical Products, Inc. | DYB |
| Jan 21, 1993 | K923681 | EXONOX PERCUTANEOUS INTRODUCER SYSTEM W/ HEMOSTASI Exonix Research Corp. | DYB |
| Nov 18, 1992 | K924491 | INTRODUCER, PERCUTANEOUS -- MODIFICATION Medamicus, Inc. | DYB |
| Oct 6, 1992 | K920908 | OVER THE NEEDLE SPLITABLE CATHETER ASSEMBLY TYPE 1 Teleflexmedical, Inc. | DYB |
| Oct 6, 1992 | K920907 | OVER THE NEEDLE SPLITABLE CATHETER W/FUNNEL LOCATO Teleflexmedical, Inc. | DYB |
| Aug 24, 1992 | K912664 | TEC ROTATING DUAL HEMOVALVE Intensive Technology, Inc. | DYB |
| Aug 12, 1992 | K920528 | CATHETER INTRODUCER Boston Scientific Corp | DYB |
| Jun 10, 1992 | K915078 | MORSE HEMOSTATIC CATHETER INTRODUCER SET North American Instrument Corp. | DYB |
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