FDA Product Code
FDA Product Code DYB — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.1340
510(k) Clearances — 706 records · page 6 of 8
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K955820 | BRAUN HEMOSTASIS INTRODUCERS | B.Braun Medical, Inc. | 1996-03-25 | Traditional | PDF ↗ |
| K955785 | TS PERCUTANEOUS ARTERIAL/VENUS CATHETER INTRO SET | C.R. Bard, Inc. | 1996-03-12 | Traditional | PDF ↗ |
| K960310 | EPIC INTRODUCER SHEATH | North American Instrument Corp. | 1996-02-07 | Traditional | PDF ↗ |
| K954595 | CORDIS BRITE TIP SHEATH INTRODUCER | Cordis Corp. | 1995-12-28 | Traditional | PDF ↗ |
| K942977 | NOVOSTE PULSE PLUS BLOOD CONTAINMENT DEVICE | Novoste Corp. | 1995-12-28 | Traditional | PDF ↗ |
| K954317 | DIAG FAST-CATH DUO & TRIO REMOVABLE HEMOSTASIS ADAPTERS W/SIDEPORTS & 3-WAY STOPCOCKS | Daig Corp. | 1995-11-28 | Traditional | PDF ↗ |
| K954234 | RADIFOCUS INTRODUCER II KIT | Terumo Medical Corp. | 1995-11-27 | Traditional | PDF ↗ |
| K952828 | MEDI-TECH PERCUTANEOUS INTRODUCER SYSTEM | Boston Scientific Corp | 1995-08-18 | Traditional | PDF ↗ |
| K940092 | USCI INPUT INTRODUCER SET | Usci, Div. C.R. Bard, Inc. | 1995-08-10 | Traditional | PDF ↗ |
| K950155 | RAPID-TRAK(TM) INTRODUCER SHEATH | Cardio Vascular Concepts, Inc. | 1995-08-02 | Traditional | PDF ↗ |
| K951313 | MEDAMICUS PERCUTANEOUS INTRODUCER | Medamicus, Inc. | 1995-06-27 | Traditional | PDF ↗ |
| K945524 | CORDIS INTRODUCING CATHETER | Cordis Corp. | 1995-04-26 | Traditional | PDF ↗ |
| K945616 | CORDIS AVANTI CATHETER SHEATH INTRODUCER | Cordis Corp. | 1995-03-29 | Traditional | PDF ↗ |
| K945396 | FLUORO-TIP(R) HEMOSTASIS VALVE INTRODUCER SET | B.Braun Medical, Inc. | 1995-03-13 | Traditional | PDF ↗ |
| K933522 | INTRODUCER NEEDLE (SEVERAL SIZES) | Mediziv Medical Products 1987 , Ltd. | 1995-02-21 | Traditional | PDF ↗ |
| K940079 | ARROW PERCUTANEOUS SHEATH INTRODUCER KIT AK-07903 | Arrow Intl., Inc. | 1994-11-30 | Traditional | PDF ↗ |
| K942191 | URESIL DILATOR | Uresil Corp. | 1994-09-21 | Traditional | PDF ↗ |
| K944107 | VIP PLUS PERCUTANEOUS INTRODUCER | Medamicus, Inc. | 1994-09-14 | Traditional | PDF ↗ |
| K941428 | EXACTA PERCUTANEOUS INTRODUCER SHEATH | Ohmeda Medical | 1994-07-06 | Traditional | PDF ↗ |
| K935077 | CATH-SEAL | Universal Medical Instrument Corp. | 1994-06-07 | Traditional | PDF ↗ |
| K934624 | ACS ROTATING HEMOSTATIC VALVE & ACS DUOSTAT ROTATING HEMOSTATIC VALVE | Advanced Cardiovascular Systems, Inc. | 1994-04-13 | Traditional | PDF ↗ |
| K930808 | PROTECTOR INTRODUCER SHEATH | Boston Scientific /International Technologies | 1994-03-15 | Traditional | PDF ↗ |
| K934901 | TEAR-AWAY SHEATH INTRODUCER SET WITH INTEGRAL HEMOSTASIS VALVE | Thomas Medical Products, Inc. | 1994-01-21 | Traditional | PDF ↗ |
| K934285 | CATHETER INTRODUCER MODIFICATION | Daig Corp. | 1993-11-24 | Traditional | PDF ↗ |
| K932323 | PERCUTANEOUS INTRODUCER | Medamicus, Inc. | 1993-11-09 | Traditional | PDF ↗ |
| K932370 | REMINGTON MEDICAL DISPOS TEAR-AWAY VASC INTRO SET | Remington Medical, Inc. | 1993-11-09 | Traditional | PDF ↗ |
| K931743 | BURRON CARDIOVASCULAR ANGESTAT(TM) | B.Braun Medical, Inc. | 1993-11-02 | Traditional | PDF ↗ |
| K931489 | INTHERM RADIALLY EXPANDING DILATING INTRODUCER | Innerdyne Medical, Inc. | 1993-10-15 | Traditional | PDF ↗ |
| K931587 | MULTI-PORT Y INTRODUCER SET | Thomas Medical Products, Inc. | 1993-10-06 | Traditional | PDF ↗ |
| K931218 | INTROPEEL V | Menlo Care, Inc. | 1993-09-22 | Traditional | PDF ↗ |
| K930801 | INTROPEEL | Menlo Care, Inc. | 1993-09-22 | Traditional | PDF ↗ |
| K930194 | HEMOSTASIS VALVE AND TUBING SET | Opticon Medical, Inc. | 1993-09-22 | Traditional | PDF ↗ |
| K931662 | LEAD INTRODUCER SET, VARIOUS MODELS AND SIZES | Pace Medical | 1993-08-31 | Traditional | PDF ↗ |
| K932733 | CORDIS CATHETER SHEATH INTRODUCER | Cordis Corp. | 1993-08-26 | Traditional | PDF ↗ |
| K930057 | ANGESTAT FLUORO-TIP HEMOSTASIS INTRODUCER SET | B.Braun Medical, Inc. | 1993-08-06 | Traditional | PDF ↗ |
| K925633 | BALT INTRODUCER | Target Therapeutics | 1993-06-25 | Traditional | PDF ↗ |
| K931102 | CORDIS NIHON CATHETER SHEATH INTRODUCER | Cordis Corp. | 1993-05-27 | Traditional | PDF ↗ |
| K926340 | NEW LEAD INTRODUCER KITS, VARIOUS MODELS | Telectronics Pacing Systems, Inc. | 1993-05-27 | Traditional | PDF ↗ |
| K924607 | ARROW FISCHELL KINK RESIST PERCUT SHEATH INTRO SET | Arrow Intl., Inc. | 1993-04-22 | Traditional | PDF ↗ |
| K924456 | LONG LENGTH PERCUTANEOUS INTRODUCER SET | Thomas Medical Products, Inc. | 1993-03-22 | Traditional | PDF ↗ |
| K923603 | INTRA-AORTIC BALLOON PUMP CATHETER - MODIFICATION | Kontron Instruments, Inc. | 1993-03-08 | Traditional | PDF ↗ |
| K924562 | CATHETER INTRODUCER | Luther Medical Products, Inc. | 1993-02-25 | Traditional | PDF ↗ |
| K923681 | EXONOX PERCUTANEOUS INTRODUCER SYSTEM W/ HEMOSTASI | Exonix Research Corp. | 1993-01-21 | Traditional | PDF ↗ |
| K924491 | INTRODUCER, PERCUTANEOUS -- MODIFICATION | Medamicus, Inc. | 1992-11-18 | Traditional | PDF ↗ |
| K920908 | OVER THE NEEDLE SPLITABLE CATHETER ASSEMBLY TYPE 1 | Teleflexmedical, Inc. | 1992-10-06 | Traditional | PDF ↗ |
| K920907 | OVER THE NEEDLE SPLITABLE CATHETER W/FUNNEL LOCATO | Teleflexmedical, Inc. | 1992-10-06 | Traditional | PDF ↗ |
| K912664 | TEC ROTATING DUAL HEMOVALVE | Intensive Technology, Inc. | 1992-08-24 | Traditional | PDF ↗ |
| K920528 | CATHETER INTRODUCER | Boston Scientific Corp | 1992-08-12 | Traditional | PDF ↗ |
| K915078 | MORSE HEMOSTATIC CATHETER INTRODUCER SET | North American Instrument Corp. | 1992-06-10 | Traditional | PDF ↗ |
| K915625 | INTRODUCER CATHETER | Interventional Therapeutics Corp. | 1992-06-03 | Traditional | PDF ↗ |
| K920998 | GORE TUNNELER, MODIFICATION | W. L. Gore & Associates, Inc. | 1992-06-03 | Traditional | PDF ↗ |
| K920779 | FAST-CATH HEMOSTASIS INTRODUCER | Daig Corp. | 1992-06-03 | Traditional | PDF ↗ |
| K920327 | DAIG FAST CATH TRANSSEPTAL SHEATH INTRODUCER | Daig Corp. | 1992-04-16 | Traditional | PDF ↗ |
| K920251 | USCI HEMAQUET XT INTRODUCER | C.R. Bard, Inc. | 1992-03-18 | Traditional | PDF ↗ |
| K915421 | GUIDEWIRE INTRODUCER SET | B. Braun of America, Inc. | 1992-02-27 | Traditional | PDF ↗ |
| K915553 | USCI(R) HEMAFLEX(TM) INTRODUCER WITH COATING | C.R. Bard, Inc. | 1992-02-21 | Traditional | PDF ↗ |
| K915167 | GESCO PER-Q-CATH CATHETER INTRODUCER | Gesco Intl., Inc. | 1992-01-27 | Traditional | PDF ↗ |
| K914330 | SOS BLOODLESS NEEDLE | E-Z-Em, Inc. | 1991-12-20 | Traditional | PDF ↗ |
| K911883 | DAIG FAST CATH(TM) TRANSSEPTAL SHEATH INTRODUCER | Diag Corp. | 1991-11-29 | Traditional | PDF ↗ |
| K914352 | CORDIS OBTURATOR | Cordis Corp. | 1991-11-22 | Traditional | PDF ↗ |
| K914046 | THE BIG EASY Y-ADAPTER | Microvena Corp. | 1991-11-08 | Traditional | PDF ↗ |
| K914090 | DAIG FAST CATH(TM) INTRODUCER, MODIFICATION | Daig Corp. | 1991-10-28 | Traditional | PDF ↗ |
| K913801 | CORDIS CATH SHEATH INTRO SYST PLUS W/UNISTASIS VAL | Cordis Corp. | 1991-10-16 | Traditional | PDF ↗ |
| K912961 | MORSE VASCULAR INTRODUCER SET | North American Instrument Corp. | 1991-09-11 | Traditional | PDF ↗ |
| K911794 | CATH SHEATH INTRODUCER SYST PLUS W/UNISTASIS VALVE | Cordis Corp. | 1991-07-19 | Traditional | PDF ↗ |
| K911678 | ROTATING HEMOSTATIC VALVE | Devices For Vascular Intervention, Inc. | 1991-07-12 | Traditional | PDF ↗ |
| K911236 | MEDTRONIC PERMANENT LEAD INTRODUCER, VARIOUS MDLS | Medtronic Vascular | 1991-06-18 | Traditional | PDF ↗ |
| K910933 | OLYMPUS ANGIOSCOPY IRRIGATION SHEATH | Olympus Corp. | 1991-06-03 | Traditional | PDF ↗ |
| K910688 | CORDIS PEEL-AWAY INSERTION TOOL | Cordis Corp. | 1991-05-16 | Traditional | PDF ↗ |
| K910861 | PERCUTANEOUS INTROD W/SIDEPORT/THREE-WAY STOPCOCK | Daig Corp. | 1991-05-07 | Traditional | PDF ↗ |
| K904475 | ENTREE SHEATH INTRODUCER SYSTEM | Cordis Corp. | 1991-04-01 | Traditional | PDF ↗ |
| K903463 | IVT INTRODUCER SHEATH | Intensive Technology, Inc. | 1991-01-03 | Traditional | PDF ↗ |
| K903410 | BIO-MEDICUS CANNULA INTRODUCER | Bio Medicus, Inc. | 1990-10-31 | Traditional | PDF ↗ |
| K903530 | PERCUTANEOUS INTRODUCERS | Davol, Inc. | 1990-10-22 | Traditional | PDF ↗ |
| K902932 | DATASCOPE PERCOR PERCUTANEOUS INTRODUCER W/PEELABL | Datascope Corp. | 1990-10-16 | Traditional | PDF ↗ |
| K903840 | GIANT LUMEN SAFETIP SERIES: ENDOMYOCARDIAL BIOPSY | Intec Medical, Inc. | 1990-10-16 | Traditional | PDF ↗ |
| K903906 | PERCUTANEOUS CATHETER INTRODUCER KIT | Intec Medical, Inc. | 1990-09-26 | Traditional | PDF ↗ |
| K902275 | PERCUTANEOUS INTRODUCER SET | Thomas Medical Products, Inc. | 1990-09-26 | Traditional | PDF ↗ |
| K902477 | WORKSTATION FEMORAL INTRAVASCULAR RETRIEVAL SET | Medical Engineering and Development Institute | 1990-08-24 | Traditional | PDF ↗ |
| K903442 | ARIES TAPERSEAL(TM) SHEATH | Aries Medical, Inc. | 1990-08-23 | Traditional | PDF ↗ |
| K900515 | MODELS 6207/6208/6209/6210/6211/6212/6214 (PLI'S) | Medtronic Vascular | 1990-08-23 | Traditional | PDF ↗ |
| K900658 | INTRODUCER, PERCUTANEOUS | Novoste Puerto Rico, Inc. | 1990-08-23 | Traditional | PDF ↗ |
| K900756 | ITC INTRODUCER CATHETER | Interventional Therapeutics Corp. | 1990-08-08 | Traditional | PDF ↗ |
| K902251 | SUBCLAVIAN INTRODUCER SET | Infusaid Corp. | 1990-07-31 | Traditional | PDF ↗ |
| K901391 | DATASCOPE PTCA PERCUTANEOUS CATHETER INTRODUCER | Datascope Corp. | 1990-06-26 | Traditional | PDF ↗ |
| K901452 | USCI(R) ACCESS(TM) INTRODUCER SET | C.R. Bard, Inc. | 1990-05-22 | Traditional | PDF ↗ |
| K895580 | Y-ADAPTER W/THOUY BORST | Angeion Corp. | 1990-04-30 | Traditional | PDF ↗ |
| K897041 | HEMAQUET(TM) AND HEMAFLEX(TM) INTRODUCERS | C.R. Bard, Inc. | 1990-03-16 | Traditional | PDF ↗ |
| K895044 | DUAL GUIDE INTRODUCER CATHETER | Cook, Inc. | 1990-02-26 | Traditional | PDF ↗ |
| K891121 | MEDI-TECH AMPLATZ INTRODUCER SHEALTH SYSTEM | Boston Scientific Corp | 1989-12-05 | Traditional | PDF ↗ |
| K894446 | ANGEION HEMOSTASIS VALVE INTRODUCER | Angeion Corp. | 1989-11-30 | Traditional | PDF ↗ |
| K895214 | HEMOSTASIS VALVE | Applied Vascular Devices, Inc. | 1989-11-14 | Traditional | PDF ↗ |
| K894445 | MODIFIED SOFTOUCH INTRODUCER W/HEMO VALVE & SIDE | Mallinckroot, Inc. | 1989-10-02 | Traditional | PDF ↗ |
| K894157 | OBTURATOR | Argon Medical Corp. | 1989-09-28 | Traditional | PDF ↗ |
| K894343 | DAIG PERCUTANEOUS CATHETER INTRO. & REMOVABLE HEMO | Daig Corp. | 1989-09-26 | Traditional | PDF ↗ |
| K890766 | CATHETER INTRODUCER SHEATH | Applied Vascular Devices, Inc. | 1989-09-18 | Traditional | PDF ↗ |
| K894431 | MODIFIED LABELING TO PERMANENT LEAD INTRODUCER | Daig Corp. | 1989-09-06 | Traditional | PDF ↗ |
| K894430 | MODIFIED LABEL TO PERCU. INTRO. W/SIDEPORT & 3-WAY | Daig Corp. | 1989-08-09 | Traditional | PDF ↗ |
| K885179 | INTRO-FLEX SHEATH INTRODUCER W/AMC THROMBOSHIELD | Baxter Healthcare Corp | 1989-08-09 | Traditional | PDF ↗ |
| K893658 | PERCUTANEOUS INTRODUCER | Medamicus, Inc. | 1989-08-03 | Traditional | PDF ↗ |
Product code DYB · Class II · Cardiovascular. Data: openFDA.