Company ยท US
Scimed Life Systems, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1977 to 1998. Name variants (Inc, Corp, punctuation) are merged.
109510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| DQX | Wire, Guide, Catheter | 30 |
| DQY | Catheter, Percutaneous | 17 |
| DQO | Catheter, Intravascular, Diagnostic | 16 |
| LIT | Catheter, Angioplasty, Peripheral, Transluminal | 13 |
| DTZ | Oxygenator, Cardiopulmonary Bypass | 6 |
| KRA | Catheter, Continuous Flush | 6 |
| DTP | Defoamer, Cardiopulmonary Bypass | 4 |
| DTL | Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass | 3 |
| DTN | Reservoir, Blood, Cardiopulmonary Bypass | 3 |
| DTR | Heat-Exchanger, Cardiopulmonary Bypass | 3 |
| MAV | Syringe, Balloon Inflation | 2 |
| DRF | Catheter, Electrode Recording, Or Probe, Electrode Recording | 1 |
| DXT | Injector And Syringe, Angiographic | 1 |
| DXZ | Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene | 1 |
| KRI | Accessory Equipment, Cardiopulmonary Bypass | 1 |
| LOX | Catheters, Transluminal Coronary Angioplasty, Percutaneous | 1 |
| MFY | Endothelial Cell Harvesting Kit | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 12, 1998 | K974241 | SCIMED INFORMER PRESSURE WIRE SYSTEM Scimed Life Systems, Inc. | DQX |
| Aug 18, 1998 | K981788 | SCIMED 6 FRENCH WISEGUIDE GUIDE CATHETER Scimed Life Systems, Inc. | DQO |
| Apr 29, 1998 | K980360 | SCIMED QUEST FLOPPY AND MODERATE SUPPORT GUIDE WIRES Scimed Life Systems, Inc. | DQX |
| Feb 23, 1998 | K974559 | SCIMED 6 FRENCH IMPULSE ANGIOGRAPHIC CATHETERS Scimed Life Systems, Inc. | DQO |
| Feb 19, 1998 | K974684 | SCIMED 7 FRENCH WISEGUIDE GUIDE CATHETER Scimed Life Systems, Inc. | DQY |
| Jan 12, 1998 | K973945 | LUGE GUIDE WIRE Scimed Life Systems, Inc. | DQX |
| Jun 3, 1997 | K970823 | SCIMED 8 FRENCH WISEGUIDE GUIDE CATHETER Scimed Life Systems, Inc. | DQY |
| May 21, 1997 | K964551 | CHOICE SUPER SUPPORT PTCA GUIDE WIRE, CHOICE PLUS SUPER SUPPORT PTCA GUIDE WIRE, CHOICE EXCHANGE SUPER SUPPORT PTCA GUID Scimed Life Systems, Inc. | DQX |
| Mar 28, 1997 | K970244 | SCIMED CHOICE FAMILY OF PTCA GUIDE WIRES Scimed Life Systems, Inc. | DQX |
| Mar 4, 1997 | K965023 | CHOICE PT PLUS PTCA GUIDE WIRE AND CHOICE PT VISION PTCA GUIDE WIRE Scimed Life Systems, Inc. | DQX |
| Feb 10, 1997 | K964859 | SCIMED 5 FRENCH IMPULSE ANGIOGRAPHIC CATHETERS Scimed Life Systems, Inc. | DQO |
| Dec 17, 1996 | K962572 | SCIMED CHOICE PT VISION PTCA GUIDE WIRE Scimed Life Systems, Inc. | DQX |
| Jul 3, 1996 | K961294 | SCIMED DISPATCH GOLD CORONARY CATHETER Scimed Life Systems, Inc. | KRA |
| May 15, 1996 | K961280 | SCIMED 6-10 F TRIGUIDE GUIDE CATHETERS 6F,7F,8F,9F & 10F Scimed Life Systems, Inc. | DQY |
| May 15, 1996 | K961015 | SCIMED CHOICE/PTCA GUIDE WIRE/PLUS PTCA GUIDE WIRE/EXCHANGE PTCA GUIDE WIRE Scimed Life Systems, Inc. | DQX |
| Apr 29, 1996 | K960657 | SCIMED CHOICE PT EXCHANGE EXTRA SUPPORT PTCA AND LONG TAPER PTCA GUIDE WIRE Scimed Life Systems, Inc. | DQX |
| Apr 29, 1996 | K960563 | SCIMED SCEPTOR & SCEPTOR EXCHANGE PTCA GUIDE WIRES Scimed Life Systems, Inc. | DQX |
| Mar 22, 1996 | K955869 | SCIMED ENCORE 26 INFLATION DEVICE/ENCORE 30 INFLATION DEVICE Scimed Life Systems, Inc. | MAV |
| Feb 23, 1996 | K953133 | SCIMED DISPATCH CORONARY INFUSION CATHETER Scimed Life Systems, Inc. | KRA |
| Jan 16, 1996 | K953265 | SCIMED ANGIOGRAPHIC KITS Scimed Life Systems, Inc. | DQY |
| Sep 19, 1995 | K953515 | SCIMED TRIGUIDE GUIDE CATHETERS Scimed Life Systems, Inc. | DQY |
| Jul 27, 1995 | K952872 | SSCIMED CORONARY GUIDE WIRE/INFUSION CATHETER Scimed Life Systems, Inc. | KRA |
| Jul 21, 1995 | K951802 | SCIMED ENCORE ADVANTAGE KIT AND THE ESSENTIALS KIT Scimed Life Systems, Inc. | DXT |
| Jun 22, 1995 | K951720 | SCIMED EXPO ANGIOGRAPHIC CATHETER Scimed Life Systems, Inc. | DQO |
| Jun 22, 1995 | K950216 | SCIMED CHOICE PT PLUS(RM) PTCA GUIDE WIRE Scimed Life Systems, Inc. | DQX |
| May 31, 1995 | K951089 | SCIMED GATEWAY PLUS Scimed Life Systems, Inc. | DTL |
| May 25, 1995 | K950835 | SCIMED CHOICE PT PTCA GUIDE WIRE Scimed Life Systems, Inc. | DQX |
| Apr 28, 1995 | K950535 | SCIMED SCEPTOR EXCHANGE GUIDE WIRE Scimed Life Systems, Inc. | DQX |
| Apr 28, 1995 | K950534 | SCIMED SCEPTOR PTCA GUIDE WIRE Scimed Life Systems, Inc. | DQX |
| Apr 14, 1995 | K950266 | SCIMED(R) CHOICE(TM) PT EXCHANGE PTCA GUIDE WIRE Scimed Life Systems, Inc. | DQX |
| Apr 5, 1995 | K950731 | SCIMED 6 FRENCH EXPO ANGIOGRAPHIC CATHETER Scimed Life Systems, Inc. | DQO |
| Mar 31, 1995 | K950141 | SCIMED(R) CHOICE(TM) PTCA GUIDE WIRE Scimed Life Systems, Inc. | DQX |
| Mar 31, 1995 | K950113 | SCIMED(R) CHICE(TM) EXCHANGE PTCA GUIDE WIRE Scimed Life Systems, Inc. | DQX |
| Mar 31, 1995 | K946240 | SCIMED(R) SCEPTOR(TM) PTCA GUIDE WIRE Scimed Life Systems, Inc. | DQX |
| Mar 17, 1995 | K946180 | SCIMED(R) ENTRE PTCA GUIDE WIRE Scimed Life Systems, Inc. | DQX |
| Mar 13, 1995 | K946204 | SCIMED(R) TRIDUIGE(R) GUIDE CATHETERS Scimed Life Systems, Inc. | DQY |
| Mar 3, 1995 | K950094 | SCIMED 6 FRENCH MICRO-MAX(TM) GUIDE CATHETER Scimed Life Systems, Inc. | DQY |
| Mar 3, 1995 | K945129 | SCIMED CHIOCE PLUS PTCA GUIDE WIRE Scimed Life Systems, Inc. | DQX |
| Jan 13, 1995 | K945593 | SCIMED(R) CORONARY GUIDE WIRE EXCHANGE/INFUSION CATHETER Scimed Life Systems, Inc. | KRA |
| Dec 30, 1994 | K945159 | SCIMED PURSUIT EXCHANGE PTCA GUIDE WIRE Scimed Life Systems, Inc. | DQX |
| Nov 22, 1994 | K943192 | SCIMED CHOICE(TM) PTCA GUIDE WIRE Scimed Life Systems, Inc. | DQO |
| Nov 14, 1994 | K944815 | SCIMED VIPER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER Scimed Life Systems, Inc. | LIT |
| Oct 21, 1994 | K944537 | SCIMED TRIGUIDE GUIDE CATHETER Scimed Life Systems, Inc. | DQY |
| Oct 13, 1994 | K943783 | 7 FRENCH LARGE LUMEN TRIGUIDE-PLUS Scimed Life Systems, Inc. | DQY |
| Oct 13, 1994 | K943777 | SCIMED 8 FRENCH BIG-MAX GUIDE CATHETER Scimed Life Systems, Inc. | DQY |
| Aug 31, 1994 | K942333 | SCIMED EN TRE' III PTCA GUIDE WIRE Scimed Life Systems, Inc. | DQX |
| Jul 27, 1994 | K931335 | SCIMED(R) VENTURE(TM) INFUSION CATHETER Scimed Life Systems, Inc. | KRA |
| Jun 22, 1994 | K941137 | SCIMED TRIGUIDE GUIDING CATHETER Scimed Life Systems, Inc. | DQY |
| May 24, 1994 | K941895 | SCIMED 0.014 PTCA GUIDE WIRE WITH ICE HYDROPHILIC COATING Scimed Life Systems, Inc. | DQX |
| May 12, 1994 | K934541 | SCIMED 6 FRENCH ANGIOGRAPHIC CATHETER MODIFICATION Scimed Life Systems, Inc. | DQO |
Newest 50 of 109.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||