Panels › Cardiovascular › Product code DRE · Class 2
Dilator, Vessel, For Percutaneous Catheterization
Regulation 870.1310
2510(k)s in 12 months (105 all time)
1recalls in 12 months (40 all time)
36recalls that name a 510(k)
Top companies in DRE
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 21, 2007 | K070159 | PRELUDE SHEATH INTRODUCER Merit Medical Systems, Inc. | DRE |
| Feb 6, 2007 | K062554 | STARCLOSE HEX-HUB DILATOR Abbott Vascular, Inc. | DRE |
| May 10, 2006 | K061000 | EVOLUTION MECHANICAL DILATOR SHEATH SET MODELS-LR-EVN-7.0, LR-EVN-9.0 Cook Vascular, Inc. | DRE |
| Jan 17, 2006 | K052557 | SUPER SHEATH INTRODUCER SHEATH Togo Medikit Co., Ltd. | DRE |
| May 6, 2005 | K050962 | MERIT PRELUDE SHEATH INTRODUCER Merit Medical Systems, Inc. | DRE |
| Sep 3, 2003 | K031691 | MERIT MAK (MINI ACCESS KIT) Merit Medical Systems, Inc. | DRE |
| Feb 20, 2003 | K030260 | GELBFISH FLEX VASCULAR DILATOR Vascumetrix, LLC | DRE |
| Nov 8, 2002 | K023507 | MODIFICATION TO GELBFISH VASCULAR DILATORS Vascumetrix, LLC | DRE |
| Dec 20, 2001 | K012256 | GELBISH VASCULAR DILATOR Vascumetrix, LLC | DRE |
| Jun 14, 2001 | K010055 | COOK VASCULAR ELECTROSURGICAL DISSECTION SHEATH Cook Vascular, Inc. | DRE |
| Aug 1, 2000 | K000737 | COAXIAL DILATOR SET Xentek Medical, Inc. | DRE |
| Dec 1, 1998 | K974617 | PERIPHERAL VASCULAR DILATOR Endovascular Instruments, Inc. | DRE |
| Apr 24, 1998 | K980282 | URESIL DILATOR WITH RADIOPAQUE MARKER Uresil Corp. | DRE |
| Mar 13, 1998 | K974640 | COAXIAL DILATOR SET Boston Scientific Corp | DRE |
| Jul 31, 1997 | K970470 | EVT EXPANDABLE SHEATH Guidant Cardiac and Vascular Surgery | DRE |
| Apr 24, 1997 | K970392 | CORDIS AVANTI+CATHETER SHEATH INTRODUCER SYSTEM Cordis Corp. | DRE |
| Apr 4, 1997 | K945586 | FLEXIBLE DILATING SHEATH Med Institute, Inc. | DRE |
| Mar 11, 1997 | K963388 | VESSEL DILATOR Maxxim Medical | DRE |
| Jul 2, 1996 | K960917 | PERCUGLIDE Scientific Device Manufacturer, LLC | DRE |
| Jan 3, 1992 | K914555 | WORKSTATION FEMORAL INTRAVASCULAR RETRIEVAL (MODI) Med Institute, Inc. | DRE |
| Nov 27, 1991 | K913027 | VESSEL DILATOR Deseret Medical, Inc. | DRE |
| Oct 9, 1991 | K912050 | NOVOSTE VESSEL DILATER Novaste Corp. | DRE |
| Mar 25, 1991 | K905416 | VESSEL DILATOR The R Group | DRE |
| Dec 10, 1990 | K904476 | VESSEL DILATOR Datascope Corp. | DRE |
| Aug 23, 1990 | K902469 | BYRD DILATOR SHEATH SET - TEFLON Medical Engineering and Development Institute | DRE |
| Jul 3, 1990 | K901815 | MODIFIED STERILIZATION OF INTRA-ART(TM) CORONARY Pioneering Technologies, Inc. | DRE |
| Apr 10, 1990 | K896096 | SOLOSTICK (AMPLATZ DILATOR NEEDLE) Microvena Corp. | DRE |
| Sep 12, 1989 | K894330 | DAIG VESSEL DILATOR Daig Corp. | DRE |
| Aug 25, 1988 | K882238 | VESSEL DILATOR AND INTRODUCER SHEATH Ideal Medical, Inc. | DRE |
| Jun 9, 1988 | K881073 | SHILEY FEMORAL CANNULAE INTRODUCER KIT Shiley, Inc. | DRE |
| May 2, 1988 | K874738 | 10 AND 12 FRENCH VESSEL DILATORS Impra, Inc. | DRE |
| Mar 25, 1988 | K875327 | MODIFIED SELDINGER INITIAL PUNCTURE INSTRUMENT Schneider-Shilley (Usa) | DRE |
| Sep 15, 1987 | K872724 | SHEATH/DILATORS Med-West, Inc. | DRE |
| Jun 1, 1987 | K870413 | PERCUTANEOUS SHEATH W/WO MEDI. (5,6,7,8,8.5FR) Medical Surgical Concepts, Inc. | DRE |
| Apr 22, 1987 | K871148 | URESIL CAROTID ARTERY SIZERS Uresil Corp. | DRE |
| Aug 19, 1986 | K862288 | MODIFICATION OF TISSUE DILATOR Quinton, Inc. | DRE |
| May 2, 1986 | K860161 | HEART CATHETERIZATION TRAY Medical Design Concepts, Inc. | DRE |
| Feb 25, 1985 | K850337 | CARDIAC CATHETERIZATION PACK Marwood Medical, Inc. | DRE |
| Sep 11, 1984 | K843261 | ANGIOSYSTEMS STANDARD ARTERIOGRAM & CARD Angiosystems, Inc. | DRE |
| Jul 13, 1984 | K842113 | AMENDMENT TO ANGIOGRAPHY KIT W/ADDIT Mallinckrodt Critical Care | DRE |
| Jul 2, 1984 | K841995 | 10.5 FRENCH DILATOR, 15CM, W/LUER LOCK Quinton, Inc. | DRE |
| Mar 12, 1984 | K840671 | CARDIAC CATHETERIZATION PACK Professional Medical Services | DRE |
| Feb 4, 1984 | K840022 | HEART CATHETERIZATION TRAY SET Medi-Plast Intl., Inc. | DRE |
| Feb 4, 1984 | K840017 | VERTEX PERCUTANEOUS CATHETER INTRODUC Professional Medical Services | DRE |
| Dec 16, 1983 | K833965 | 8 FRENCH DILATOR 15CM, W/LUER LOCK Quinton, Inc. | DRE |
| May 9, 1983 | K831190 | VESSEL DILATOR Medrad, Inc. | DRE |
| Sep 28, 1982 | K822595 | VESSEL DILATOR Vertex Medical Corp. | DRE |
| Dec 29, 1981 | K813461 | PERCUTANEOUS ENTRY NEEDLE, SELDINGER Ocean Medical Products, Ltd. | DRE |
| Dec 14, 1981 | K813125 | MICRO TRANSDUCER CATHETERS Honeywell, Inc. | DRE |
| Apr 11, 1981 | K810859 | SINGLE USE SELDINGER/COURNAND PERC. NDL Procedure Products, Inc. | DRE |
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