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 16, 1985 | K851141 | TELEFLEX MEDICAL INTRODUCER CATHETER Teleflexmedical, Inc. | DYB |
| May 16, 1985 | K844840 | DESERET INTRODUCER SET Parke-Davis Co. | DYB |
| Apr 19, 1985 | K851078 | HDC SILCATH SUBCLAVIAN CATHETER PERCUTANEOUS INSER Hdc Corp. | DYB |
| Apr 10, 1985 | K850820 | PERCUTANEOUS CATHETER INTRODUCER W/CATH-SEAL & SID Universal Medical Instrument Corp. | DYB |
| Mar 6, 1985 | K844693 | PEEL-AWAY INTRODUCER SET Quinton, Inc. | DYB |
| Dec 27, 1984 | K843798 | MEADOX SURGIMED A/S CATHETER SHEATH SYS Meadox Surgimed, Inc. | DYB |
| Nov 13, 1984 | K843118 | CANNULA INTRODUCER Cardiovascular Research, Inc. | DYB |
| Oct 23, 1984 | K843642 | SUBCLAVIAN LEAD INTRODUCER SYS Xanmed Corp. | DYB |
| Oct 23, 1984 | K843641 | CATHETER INTRODUCER SYSTEM Xanmed Corp. | DYB |
| Oct 18, 1984 | K843719 | SINGLE WALL INTRODUCER NEEDLE Ocean Medical Products, Ltd. | DYB |
| Oct 18, 1984 | K843500 | FRENCH 7 TRI-ACCESS COMPACT CENTRAL VEIN Cardio-Vascular Innovations, Inc. | DYB |
| Aug 3, 1984 | K842780 | MEDTRONIC 6210 PERMANENT LEAD INTRODUC Medtronic Vascular | DYB |
| Aug 1, 1984 | K842259 | PCI W/CATH-SEAL SIDE FLOW FITTING Universal Medical Instrument Corp. | DYB |
| Jul 13, 1984 | K842004 | PERCUTANEOUS CATHETER INTRODUCER SET Aries Medical, Inc. | DYB |
| May 23, 1984 | K840455 | EMERGENCY INFUSION DEVICE Arrow Intl., Inc. | DYB |
| Apr 17, 1984 | K840923 | ANGIOGRAPHY NEEDLE W/WO CONNECTION Dlp, Inc. | DYB |
| Mar 19, 1984 | K834074 | PERCUTANEOUS SHEATH INTRODUCER TRAY Packaging Technologies, Inc. | DYB |
| Oct 20, 1983 | K831751 | LEAD INTRODUCER SETS-EB-S8 & EB-S12 Oscor, Inc. | DYB |
| Apr 28, 1983 | K830829 | CORONARY GUIDING CATHETER Advanced Cardiovascular Systems, Inc. | DYB |
| Apr 28, 1983 | K830813 | FRENCH PERCUTANEOUS SHEATH INTRODUCER Norton Performance Plastics Corp. | DYB |
| Jan 18, 1983 | K823262 | MODEL SP5800 #8 FRENCH INTRO. KIT Gould, Inc. | DYB |
| Nov 1, 1982 | K822834 | ACCESS PERCUTANEOUS INTRODUCER SET Access Devices, Inc. | DYB |
| Sep 28, 1982 | K822593 | PERCUTANEOUS CATHETER INTRODUCER SET Vertex Medical Corp. | DYB |
| Aug 19, 1982 | K822247 | CATH-SEAL Universal Medical Instrument Corp. | DYB |
| Jul 14, 1982 | K821324 | ARGYLE INTRAMEDICUT CATHETER KIT Sherwood Medical Co. | DYB |
| Jul 8, 1982 | K821188 | INTRODUCER SET Advanced Cardiovascular Systems, Inc. | DYB |
| Apr 14, 1982 | K820834 | PERCOR PERCUTANEOUS INTRODUCER Datascope Corp. | DYB |
| Apr 1, 1982 | K820710 | NEONATAL INTRODUCER KIT Norton Performance Plastics Corp. | DYB |
| Mar 18, 1982 | K820581 | NORTON JUGULAR KITS Norton Performance Plastics Corp. | DYB |
| Nov 27, 1981 | K813143 | DESILET Exco, Inc. | DYB |
| Nov 16, 1981 | K813019 | PERCUTANEOUS INTRODUCER: SELDINGER STYLE Dip, Inc. | DYB |
| Nov 16, 1981 | K812973 | PERCUTANEOUS INTRODUCER COURNAND STYLE Dip, Inc. | DYB |
| Nov 16, 1981 | K812964 | INTRODUCER, PERCUTANEOUS SELDINGER Triad Medical Division | DYB |
| Oct 13, 1981 | K812502 | IMPLANTAID LEAD INTRODUCER #319-10 & 12 Intermedics, Inc. | DYB |
| Sep 21, 1981 | K812325 | INTK-08 8 FRENCH INTRODUCER KIT W/SIDE Sorensen Research | DYB |
| Aug 18, 1981 | K812143 | INTRODUCER, PERCUTANEOUS Willson | DYB |
| May 28, 1980 | K800356 | PERMANENT LEAD INTRADUCER Daig Corp. | DYB |
| Apr 24, 1980 | K800621 | PERCUTANEOUS CATHETER INTRODUCER ADAPTER Norton Performance Plastics Corp. | DYB |
| Apr 24, 1980 | K800620 | VENOUS M/A INTERNAL JUGULAR KIT Norton Performance Plastics Corp. | DYB |
| Apr 24, 1980 | K800619 | THERMODILUTION CATHETER INTRO. KIT Norton Performance Plastics Corp. | DYB |
| Apr 2, 1980 | K800580 | PERCUTANEOUS CATHETER INTRODUCER Alva Medical, Inc. | DYB |
| Nov 13, 1979 | K792172 | PERCUTANEOUS SHEATH INTRO. KIT OR TRAY Stanco Medical, Inc. | DYB |
| Nov 13, 1979 | K792171 | COMPLETE TRAY CENTRAL VENOUS PRESSURE Stanco Medical, Inc. | DYB |
| Nov 13, 1979 | K792170 | PERCUTANEOUS SHEATH (MULTI-CATH)SIDE Stanco Medical, Inc. | DYB |
| Nov 13, 1979 | K792131 | TEMPORARY TRANSVENOUS PACMKER. ELECTRODE Stanco Medical, Inc. | DYB |
| Nov 13, 1979 | K792130 | TRANSVENOUS BALLOON CATH. INTRO. KIT Stanco Medical, Inc. | DYB |
| Nov 13, 1979 | K791963 | USCI MULLINS TRANSSEPTAL CATHETER INTRO. C.R. Bard, Inc. | DYB |
| Jul 17, 1979 | K791129 | PERMANENT LEAD INTRADUCER Daig Corp. | DYB |
| Feb 1, 1979 | K790034 | INTRODUCERS Clincal Instruments Corp. | DYB |
| Nov 29, 1978 | K781954 | CATHETER INTRODUCERS, ARTERISE C.R. Bard, Inc. | DYB |
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