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 7 of 8
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K891022 | INTRODUCER FOR PTCA GUIDING CATHETERS | Argon Medical Corp. | 1989-05-19 | Traditional | PDF ↗ |
| K890277 | HEMOSTASIS VALVE, WITH OR WITHOUT SIDE PORT | Oscor Medical Corp. | 1989-03-10 | Traditional | PDF ↗ |
| K884494 | DAIG OBTURATOR, CATHETER INTRODUCER | Daig Corp. | 1989-02-22 | Traditional | PDF ↗ |
| K884159 | SOFTOUCH INTRODUCER W/HEMOSTASIS VALVE & SIDEPORT | Mallinckroot, Inc. | 1989-02-22 | Traditional | PDF ↗ |
| K884104 | USCI(R) HEMAQUET(TM) INTRODUCER W/OBTURATOR | C.R. Bard, Inc. | 1988-12-21 | Traditional | PDF ↗ |
| K882657 | HARBOR S.E.A.-PORT SURGICAL ACCESSORY KIT | Harbor Medical Devices, Inc. | 1988-12-13 | Traditional | PDF ↗ |
| K883933 | INTRODUCING CATHETER | Devices For Vascular Intervention, Inc. | 1988-12-02 | Traditional | PDF ↗ |
| K881825 | MODELS SP5825/SP5835/SP5845/SP5855 PERCU. SHEATH | Spectramed, Inc. | 1988-09-28 | Traditional | PDF ↗ |
| K882221 | OVER THE NEEDLE CATHETER, ARTERIAL CATHETER NEEDLE | Argon Medical Corp. | 1988-08-12 | Traditional | PDF ↗ |
| K875158 | ACS FUNNEL INTRODUCER | Advanced Cardiovascular Systems, Inc. | 1988-05-31 | Traditional | PDF ↗ |
| K873100 | OLYMPUS ANGIOSCOPY SHEATH | Olympus Corp. | 1988-02-29 | Traditional | PDF ↗ |
| K873195 | SCHNEIDER-SHILEY ANGIOPORT(TM) PTCA INTRO W/HEMO | Angiomedics, Inc. | 1987-12-15 | Traditional | PDF ↗ |
| K873727 | PULL-APART INTRODUCER (SHEATH) | Quinton, Inc. | 1987-10-07 | Traditional | PDF ↗ |
| K873394 | OVAL PULL-APART SHEATH/DILATOR | Quinton, Inc. | 1987-09-30 | Traditional | PDF ↗ |
| K871153 | CATHETER INTRODUCER | Angeion Corp. | 1987-06-24 | Traditional | PDF ↗ |
| K871208 | UNIPOLAR ENDOCARDIAL SCREW-IN LEAD, MODEL 1007M | Pacesetter Systems | 1987-06-05 | Traditional | PDF ↗ |
| K870542 | VASCATH VASCULAR CATHETER PLACEMENT KIT | Titan Medical, Inc. | 1987-04-27 | Traditional | PDF ↗ |
| K871140 | ARIES PEEL AWAY PERCUTANEOUS CATHETER INTRODUCER | Aries Medical, Inc. | 1987-04-22 | Traditional | PDF ↗ |
| K871132 | PHARMACIA DELTEC SUBCLAVIAN INTRODUCERS | Deltec Systems, Inc. | 1987-04-20 | Traditional | PDF ↗ |
| K870907 | INTRODUCER, PERCUTANEOUS | Med Fusion Systems, Inc. | 1987-04-09 | Traditional | PDF ↗ |
| K870374 | PERCUTANEOUS INTRODUCER W/SIDE PORT 3 WAY STOPCOCK | Daig Corp. | 1987-03-18 | Traditional | PDF ↗ |
| K870189 | ARIES TAPERED SHEATH | Aries Medical, Inc. | 1987-03-16 | Traditional | PDF ↗ |
| K864705 | MODIFICATION (MATERIAL CHANGE) OF PEEL-AWAY SHEATH | Quinton, Inc. | 1987-02-13 | Traditional | PDF ↗ |
| K864352 | MODIFIED PEEL-AWAY INTRODUCER SET LINE | Quinton, Inc. | 1987-01-06 | Traditional | PDF ↗ |
| K863917 | CVI 8.5 FRENCH PERCUTANEOUS SHEATH INTRODUCER SYS. | Cardio-Vascular Innovations, Inc. | 1987-01-06 | Traditional | PDF ↗ |
| K863139 | TERUMO RADIFOCUS INTRODUCER KIT | Terumo Medical Corp. | 1986-10-10 | Traditional | PDF ↗ |
| K861984 | UMI CATH-SEAL, 13+14F & TRANSSEPTAL CATHETER INTRO | Universal Medical Instrument Corp. | 1986-08-05 | Traditional | PDF ↗ |
| K861238 | ANGIOMEDICS CATH SHEATH INTRODUC W/HEMOSTASIS VALV | Angiomedics, Inc. | 1986-07-16 | Traditional | PDF ↗ |
| K861951 | MODIFIED TELEFLEX MEDICAL INTRODUCER CATHETER | Teleflex, Inc. | 1986-06-19 | Traditional | PDF ↗ |
| K860307 | PEEL AWAY & SPLIT SHEATH PERCU CATH INTRODUCER SET | Teleflex, Inc. | 1986-05-20 | Traditional | PDF ↗ |
| K861082 | CORDIS CATH SHEATH INTRODUC/MID-LENGTH SHEATH SYST | Cordis Corp. | 1986-05-05 | Traditional | PDF ↗ |
| K860898 | SUBCLAVIAN INTRODUCER SET | Infusaid Corp. | 1986-04-29 | Traditional | PDF ↗ |
| K860958 | CATHETER INTRODUCER | Target Therapeutics | 1986-04-23 | Traditional | PDF ↗ |
| K855060 | CURITY PERCUTANEOUS CATHETER INSERTION TRAY | The Kendal Co. | 1986-04-16 | Traditional | PDF ↗ |
| K854941 | PMS PERCUTANEOUS PUNCTURE NEEDLE | Professional Medical Services | 1986-04-16 | Traditional | PDF ↗ |
| K855061 | CURITY PERCUTANEOUS CATHETER INSERTION KIT | The Kendal Co. | 1986-04-16 | Traditional | PDF ↗ |
| K860432 | PERCUTANEOUS INTRODUCER KIT | Cormed, Inc., Sub. C.R.Bard, Inc. | 1986-03-31 | Traditional | PDF ↗ |
| K854831 | VALVOKIT | Novamed Products, Inc. | 1986-03-31 | Traditional | PDF ↗ |
| K855126 | CORDIS CATHETER SHEATH INTRODUCERS,STERI-SLEEVES | Cordis Corp. | 1986-02-26 | Traditional | PDF ↗ |
| K854559 | MEDTRONIC PERMANENT LEAD INTRODUCER | Medtronic Vascular | 1985-12-24 | Traditional | PDF ↗ |
| K853072 | CORON PRES MONITOR KIT MODEL 80 LEFT KIT MODEL 90 | Camino Laboratories, Inc. | 1985-12-09 | Traditional | PDF ↗ |
| K853100 | COBE CATHETER W/GUIDEWIRE ASSEMBLY KIT | Cobe Laboratories, Inc. | 1985-09-25 | Traditional | PDF ↗ |
| K852880 | PEEL-AWAY SHEATH(A COMPONENT OF ARGON INTROD SET) | Argon Medical Corp. | 1985-08-29 | Traditional | PDF ↗ |
| K851947 | PTCA GUIDING CATHETER | Cordis Corp. | 1985-08-16 | Traditional | PDF ↗ |
| K852916 | SLIM VENT BIPO PACING LEAD USING A90 INSUL,#30-284 | Telectronics, Inc. | 1985-07-29 | Traditional | PDF ↗ |
| K852918 | SLIM ART J. BIP PACING LEAD USING POLY #030-2821 | Telectronics, Inc. | 1985-07-29 | Traditional | PDF ↗ |
| K852917 | SLIM ART/J-SVC IND PACING LEAD USING POLY #30-283 | Telectronics, Inc. | 1985-07-29 | Traditional | PDF ↗ |
| K844593 | CARDIOVASCULAR CUSTOM SURGICAL KIT | Xanmed Corp. | 1985-06-21 | Traditional | PDF ↗ |
| K845037 | PERCUTANEOUS ANGIOGRAPHIC NEEDLES | Mallinckrodt Critical Care | 1985-06-21 | Traditional | PDF ↗ |
| K844840 | DESERET INTRODUCER SET | Parke-Davis Co. | 1985-05-16 | Traditional | PDF ↗ |
| K851141 | TELEFLEX MEDICAL INTRODUCER CATHETER | Teleflexmedical, Inc. | 1985-05-16 | Traditional | PDF ↗ |
| K851078 | HDC SILCATH SUBCLAVIAN CATHETER PERCUTANEOUS INSER | Hdc Corp. | 1985-04-19 | Traditional | PDF ↗ |
| K850820 | PERCUTANEOUS CATHETER INTRODUCER W/CATH-SEAL & SID | Universal Medical Instrument Corp. | 1985-04-10 | Traditional | PDF ↗ |
| K844693 | PEEL-AWAY INTRODUCER SET | Quinton, Inc. | 1985-03-06 | Traditional | PDF ↗ |
| K843798 | MEADOX SURGIMED A/S CATHETER SHEATH SYS | Meadox Surgimed, Inc. | 1984-12-27 | Traditional | PDF ↗ |
| K843118 | CANNULA INTRODUCER | Cardiovascular Research, Inc. | 1984-11-13 | Traditional | PDF ↗ |
| K843641 | CATHETER INTRODUCER SYSTEM | Xanmed Corp. | 1984-10-23 | Traditional | PDF ↗ |
| K843642 | SUBCLAVIAN LEAD INTRODUCER SYS | Xanmed Corp. | 1984-10-23 | Traditional | PDF ↗ |
| K843719 | SINGLE WALL INTRODUCER NEEDLE | Ocean Medical Products, Ltd. | 1984-10-18 | Traditional | PDF ↗ |
| K843500 | FRENCH 7 TRI-ACCESS COMPACT CENTRAL VEIN | Cardio-Vascular Innovations, Inc. | 1984-10-18 | Traditional | PDF ↗ |
| K842780 | MEDTRONIC 6210 PERMANENT LEAD INTRODUC | Medtronic Vascular | 1984-08-03 | Traditional | PDF ↗ |
| K842259 | PCI W/CATH-SEAL SIDE FLOW FITTING | Universal Medical Instrument Corp. | 1984-08-01 | Traditional | PDF ↗ |
| K842004 | PERCUTANEOUS CATHETER INTRODUCER SET | Aries Medical, Inc. | 1984-07-13 | Traditional | PDF ↗ |
| K840455 | EMERGENCY INFUSION DEVICE | Arrow Intl., Inc. | 1984-05-23 | Traditional | PDF ↗ |
| K840923 | ANGIOGRAPHY NEEDLE W/WO CONNECTION | Dlp, Inc. | 1984-04-17 | Traditional | PDF ↗ |
| K834074 | PERCUTANEOUS SHEATH INTRODUCER TRAY | Packaging Technologies, Inc. | 1984-03-19 | Traditional | PDF ↗ |
| K831751 | LEAD INTRODUCER SETS-EB-S8 & EB-S12 | Oscor, Inc. | 1983-10-20 | Traditional | PDF ↗ |
| K830829 | CORONARY GUIDING CATHETER | Advanced Cardiovascular Systems, Inc. | 1983-04-28 | Traditional | PDF ↗ |
| K830813 | FRENCH PERCUTANEOUS SHEATH INTRODUCER | Norton Performance Plastics Corp. | 1983-04-28 | Traditional | PDF ↗ |
| K823262 | MODEL SP5800 #8 FRENCH INTRO. KIT | Gould, Inc. | 1983-01-18 | Traditional | PDF ↗ |
| K822834 | ACCESS PERCUTANEOUS INTRODUCER SET | Access Devices, Inc. | 1982-11-01 | Traditional | PDF ↗ |
| K822593 | PERCUTANEOUS CATHETER INTRODUCER SET | Vertex Medical Corp. | 1982-09-28 | Traditional | PDF ↗ |
| K822247 | CATH-SEAL | Universal Medical Instrument Corp. | 1982-08-19 | Traditional | PDF ↗ |
| K821324 | ARGYLE INTRAMEDICUT CATHETER KIT | Sherwood Medical Co. | 1982-07-14 | Traditional | PDF ↗ |
| K821188 | INTRODUCER SET | Advanced Cardiovascular Systems, Inc. | 1982-07-08 | Traditional | PDF ↗ |
| K820834 | PERCOR PERCUTANEOUS INTRODUCER | Datascope Corp. | 1982-04-14 | Traditional | PDF ↗ |
| K820710 | NEONATAL INTRODUCER KIT | Norton Performance Plastics Corp. | 1982-04-01 | Traditional | PDF ↗ |
| K820581 | NORTON JUGULAR KITS | Norton Performance Plastics Corp. | 1982-03-18 | Traditional | PDF ↗ |
| K813143 | DESILET | Exco, Inc. | 1981-11-27 | Traditional | PDF ↗ |
| K813019 | PERCUTANEOUS INTRODUCER: SELDINGER STYLE | Dip, Inc. | 1981-11-16 | Traditional | PDF ↗ |
| K812964 | INTRODUCER, PERCUTANEOUS SELDINGER | Triad Medical Division | 1981-11-16 | Traditional | PDF ↗ |
| K812973 | PERCUTANEOUS INTRODUCER COURNAND STYLE | Dip, Inc. | 1981-11-16 | Traditional | PDF ↗ |
| K812502 | IMPLANTAID LEAD INTRODUCER #319-10 & 12 | Intermedics, Inc. | 1981-10-13 | Traditional | PDF ↗ |
| K812325 | INTK-08 8 FRENCH INTRODUCER KIT W/SIDE | Sorensen Research | 1981-09-21 | Traditional | PDF ↗ |
| K812143 | INTRODUCER, PERCUTANEOUS | Willson | 1981-08-18 | Traditional | PDF ↗ |
| K800356 | PERMANENT LEAD INTRADUCER | Daig Corp. | 1980-05-28 | Traditional | PDF ↗ |
| K800619 | THERMODILUTION CATHETER INTRO. KIT | Norton Performance Plastics Corp. | 1980-04-24 | Traditional | PDF ↗ |
| K800620 | VENOUS M/A INTERNAL JUGULAR KIT | Norton Performance Plastics Corp. | 1980-04-24 | Traditional | PDF ↗ |
| K800621 | PERCUTANEOUS CATHETER INTRODUCER ADAPTER | Norton Performance Plastics Corp. | 1980-04-24 | Traditional | PDF ↗ |
| K800580 | PERCUTANEOUS CATHETER INTRODUCER | Alva Medical, Inc. | 1980-04-02 | Traditional | PDF ↗ |
| K792130 | TRANSVENOUS BALLOON CATH. INTRO. KIT | Stanco Medical, Inc. | 1979-11-13 | Traditional | PDF ↗ |
| K792171 | COMPLETE TRAY CENTRAL VENOUS PRESSURE | Stanco Medical, Inc. | 1979-11-13 | Traditional | PDF ↗ |
| K792131 | TEMPORARY TRANSVENOUS PACMKER. ELECTRODE | Stanco Medical, Inc. | 1979-11-13 | Traditional | PDF ↗ |
| K792172 | PERCUTANEOUS SHEATH INTRO. KIT OR TRAY | Stanco Medical, Inc. | 1979-11-13 | Traditional | PDF ↗ |
| K792170 | PERCUTANEOUS SHEATH (MULTI-CATH)SIDE | Stanco Medical, Inc. | 1979-11-13 | Traditional | PDF ↗ |
| K791963 | USCI MULLINS TRANSSEPTAL CATHETER INTRO. | C.R. Bard, Inc. | 1979-11-13 | Traditional | PDF ↗ |
| K791129 | PERMANENT LEAD INTRADUCER | Daig Corp. | 1979-07-17 | Traditional | PDF ↗ |
| K790034 | INTRODUCERS | Clincal Instruments Corp. | 1979-02-01 | Traditional | PDF ↗ |
| K781954 | CATHETER INTRODUCERS, ARTERISE | C.R. Bard, Inc. | 1978-11-29 | Traditional | PDF ↗ |
| K780532 | PERCUTANEOUS SHEATH INTRODUCER KIT | Arrow Intl., Inc. | 1978-04-21 | Traditional | PDF ↗ |
Product code DYB · Class II · Cardiovascular. Data: openFDA.