Scimed Life Systems, Inc.
Mchenry, IL, US
Scimed Life Systems, Inc. appears in FDA device records in Mchenry, IL. FDA records list 109 510(k) clearances between and , 249 PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 109
- PMA records
- 249
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
Showing 50 of 109FDA records hold 109 510(k) clearances for Scimed Life Systems, Inc. between 1977 and 1998. The busiest year on record is 1994, with 20. The most recent is 1998, with 6.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1977 | 1 |
| 1978 | 1 |
| 1979 | 1 |
| 1982 | 2 |
| 1983 | 3 |
| 1984 | 4 |
| 1985 | 3 |
| 1986 | 3 |
| 1988 | 6 |
| 1989 | 2 |
| 1990 | 2 |
| 1991 | 6 |
| 1992 | 5 |
| 1993 | 11 |
| 1994 | 20 |
| 1995 | 19 |
| 1996 | 9 |
| 1997 | 5 |
| 1998 | 6 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K974241 | SCIMED INFORMER PRESSURE WIRE SYSTEM | DQX | Substantially Equivalent | |
| K981788 | SCIMED 6 FRENCH WISEGUIDE GUIDE CATHETER | DQO | Substantially Equivalent | |
| K980360 | SCIMED QUEST FLOPPY AND MODERATE SUPPORT GUIDE WIRES | DQX | Substantially Equivalent | |
| K974559 | SCIMED 6 FRENCH IMPULSE ANGIOGRAPHIC CATHETERS | DQO | Substantially Equivalent | |
| K974684 | SCIMED 7 FRENCH WISEGUIDE GUIDE CATHETER | DQY | Substantially Equivalent | |
| K973945 | LUGE GUIDE WIRE | DQX | Substantially Equivalent | |
| K970823 | SCIMED 8 FRENCH WISEGUIDE GUIDE CATHETER | DQY | Substantially Equivalent | |
| K964551 | CHOICE SUPER SUPPORT PTCA GUIDE WIRE, CHOICE PLUS SUPER SUPPORT PTCA GUIDE WIRE, CHOICE EXCHANGE SUPER SUPPORT PTCA GUID | DQX | Substantially Equivalent | |
| K970244 | SCIMED CHOICE FAMILY OF PTCA GUIDE WIRES | DQX | Substantially Equivalent | |
| K965023 | CHOICE PT PLUS PTCA GUIDE WIRE AND CHOICE PT VISION PTCA GUIDE WIRE | DQX | Substantially Equivalent | |
| K964859 | SCIMED 5 FRENCH IMPULSE ANGIOGRAPHIC CATHETERS | DQO | Substantially Equivalent | |
| K962572 | SCIMED CHOICE PT VISION PTCA GUIDE WIRE | DQX | Substantially Equivalent | |
| K961294 | SCIMED DISPATCH GOLD CORONARY CATHETER | KRA | Substantially Equivalent | |
| K961280 | SCIMED 6-10 F TRIGUIDE GUIDE CATHETERS 6F,7F,8F,9F & 10F | DQY | Substantially Equivalent | |
| K961015 | SCIMED CHOICE/PTCA GUIDE WIRE/PLUS PTCA GUIDE WIRE/EXCHANGE PTCA GUIDE WIRE | DQX | Substantially Equivalent | |
| K960657 | SCIMED CHOICE PT EXCHANGE EXTRA SUPPORT PTCA AND LONG TAPER PTCA GUIDE WIRE | DQX | Substantially Equivalent | |
| K960563 | SCIMED SCEPTOR & SCEPTOR EXCHANGE PTCA GUIDE WIRES | DQX | Substantially Equivalent | |
| K955869 | SCIMED ENCORE 26 INFLATION DEVICE/ENCORE 30 INFLATION DEVICE | MAV | Substantially Equivalent | |
| K953133 | SCIMED DISPATCH CORONARY INFUSION CATHETER | KRA | Substantially Equivalent | |
| K953265 | SCIMED ANGIOGRAPHIC KITS | DQY | Substantially Equivalent | |
| K953515 | SCIMED TRIGUIDE GUIDE CATHETERS | DQY | Substantially Equivalent | |
| K952872 | SSCIMED CORONARY GUIDE WIRE/INFUSION CATHETER | KRA | Substantially Equivalent | |
| K951802 | SCIMED ENCORE ADVANTAGE KIT AND THE ESSENTIALS KIT | DXT | Substantially Equivalent | |
| K951720 | SCIMED EXPO ANGIOGRAPHIC CATHETER | DQO | Substantially Equivalent | |
| K950216 | SCIMED CHOICE PT PLUS(RM) PTCA GUIDE WIRE | DQX | Substantially Equivalent | |
| K951089 | SCIMED GATEWAY PLUS | DTL | Substantially Equivalent | |
| K950835 | SCIMED CHOICE PT PTCA GUIDE WIRE | DQX | Substantially Equivalent | |
| K950535 | SCIMED SCEPTOR EXCHANGE GUIDE WIRE | DQX | Substantially Equivalent | |
| K950534 | SCIMED SCEPTOR PTCA GUIDE WIRE | DQX | Substantially Equivalent | |
| K950266 | SCIMED(R) CHOICE(TM) PT EXCHANGE PTCA GUIDE WIRE | DQX | Substantially Equivalent | |
| K950731 | SCIMED 6 FRENCH EXPO ANGIOGRAPHIC CATHETER | DQO | Substantially Equivalent | |
| K950141 | SCIMED(R) CHOICE(TM) PTCA GUIDE WIRE | DQX | Substantially Equivalent | |
| K950113 | SCIMED(R) CHICE(TM) EXCHANGE PTCA GUIDE WIRE | DQX | Substantially Equivalent | |
| K946240 | SCIMED(R) SCEPTOR(TM) PTCA GUIDE WIRE | DQX | Substantially Equivalent | |
| K946180 | SCIMED(R) ENTRE PTCA GUIDE WIRE | DQX | Substantially Equivalent | |
| K946204 | SCIMED(R) TRIDUIGE(R) GUIDE CATHETERS | DQY | Substantially Equivalent | |
| K950094 | SCIMED 6 FRENCH MICRO-MAX(TM) GUIDE CATHETER | DQY | Substantially Equivalent | |
| K945129 | SCIMED CHIOCE PLUS PTCA GUIDE WIRE | DQX | Substantially Equivalent | |
| K945593 | SCIMED(R) CORONARY GUIDE WIRE EXCHANGE/INFUSION CATHETER | KRA | Substantially Equivalent | |
| K945159 | SCIMED PURSUIT EXCHANGE PTCA GUIDE WIRE | DQX | Substantially Equivalent | |
| K943192 | SCIMED CHOICE(TM) PTCA GUIDE WIRE | DQO | Substantially Equivalent | |
| K944815 | SCIMED VIPER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER | LIT | Substantially Equivalent | |
| K944537 | SCIMED TRIGUIDE GUIDE CATHETER | DQY | Substantially Equivalent | |
| K943783 | 7 FRENCH LARGE LUMEN TRIGUIDE-PLUS | DQY | Substantially Equivalent | |
| K943777 | SCIMED 8 FRENCH BIG-MAX GUIDE CATHETER | DQY | Substantially Equivalent | |
| K942333 | SCIMED EN TRE' III PTCA GUIDE WIRE | DQX | Substantially Equivalent | |
| K931335 | SCIMED(R) VENTURE(TM) INFUSION CATHETER | KRA | Substantially Equivalent | |
| K941137 | SCIMED TRIGUIDE GUIDING CATHETER | DQY | Substantially Equivalent | |
| K941895 | SCIMED 0.014 PTCA GUIDE WIRE WITH ICE HYDROPHILIC COATING | DQX | Substantially Equivalent | |
| K934541 | SCIMED 6 FRENCH ANGIOGRAPHIC CATHETER MODIFICATION | DQO | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- KRIAccessory Equipment, Cardiopulmonary Bypass
- DTLAdaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
- LITCatheter, Angioplasty, Peripheral, Transluminal
- KRACatheter, Continuous Flush
- DRFCatheter, Electrode Recording, Or Probe, Electrode Recording
- DQOCatheter, Intravascular, Diagnostic
- DQYCatheter, Percutaneous
- LOXCatheters, Transluminal Coronary Angioplasty, Percutaneous
- DTPDefoamer, Cardiopulmonary Bypass
- MFYEndothelial Cell Harvesting Kit
- DTRHeat-Exchanger, Cardiopulmonary Bypass
- DXTInjector And Syringe, Angiographic
- DTZOxygenator, Cardiopulmonary Bypass
- DXZPatch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
- DTNReservoir, Blood, Cardiopulmonary Bypass
- MAVSyringe, Balloon Inflation
- DQXWire, Guide, Catheter
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets Scimed Life Systems, Inc. edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
The self-serve claim needs an FDA establishment registration, FEI or owner-operator number on the company’s record, and we hold none for Scimed Life Systems, Inc.. The only route for a company with no identifier on record is a person here: write to us, and one looks at the record and sends the same claim link by hand.
Data as of , FDA export datePage updated Source: openFDA, public domain