Scimed Life Systems, Inc. FDA Record
- No warning letters matched by name
Scimed Life Systems, Inc. has 0 FDA recalls, 0 inspections, 109 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Scimed Life Systems, Inc." is on file.
- Latest 510(k)
- Nov 12, 1998
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 11, 2026 (checked Nov 15, 2026, unchanged) | File dated Nov 10, 2026 | Current |
| 510(k) clearances | 109 | Nov 15, 2026 | File dated Nov 9, 2026 | Current |
| Inspections | 0 | Nov 15, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
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Recent 510(k) clearances
| K-Number | Device | Date |
|---|---|---|
| K974241 | SCIMED INFORMER PRESSURE WIRE SYSTEM | Nov 12, 1998 |
| K981788 | SCIMED 6 FRENCH WISEGUIDE GUIDE CATHETER | Aug 18, 1998 |
| K980360 | SCIMED QUEST FLOPPY AND MODERATE SUPPORT GUIDE WIRES | Apr 29, 1998 |
| K974559 | SCIMED 6 FRENCH IMPULSE ANGIOGRAPHIC CATHETERS | Feb 23, 1998 |
| K974684 | SCIMED 7 FRENCH WISEGUIDE GUIDE CATHETER | Feb 19, 1998 |
| K973945 | LUGE GUIDE WIRE | Jan 12, 1998 |
| K970823 | SCIMED 8 FRENCH WISEGUIDE GUIDE CATHETER | Jun 3, 1997 |
| K964551 | CHOICE SUPER SUPPORT PTCA GUIDE WIRE, CHOICE PLUS SUPER SUPPORT PTCA GUIDE WIRE, CHOICE EXCHANGE… | May 21, 1997 |
| K970244 | SCIMED CHOICE FAMILY OF PTCA GUIDE WIRES | Mar 28, 1997 |
| K965023 | CHOICE PT PLUS PTCA GUIDE WIRE AND CHOICE PT VISION PTCA GUIDE WIRE | Mar 4, 1997 |
| K964859 | SCIMED 5 FRENCH IMPULSE ANGIOGRAPHIC CATHETERS | Feb 10, 1997 |
| K962572 | SCIMED CHOICE PT VISION PTCA GUIDE WIRE | Dec 17, 1996 |
| K961294 | SCIMED DISPATCH GOLD CORONARY CATHETER | Jul 3, 1996 |
| K961015 | SCIMED CHOICE/PTCA GUIDE WIRE/PLUS PTCA GUIDE WIRE/EXCHANGE PTCA GUIDE WIRE | May 15, 1996 |
| K961280 | SCIMED 6-10 F TRIGUIDE GUIDE CATHETERS 6F,7F,8F,9F & 10F | May 15, 1996 |
| K960563 | SCIMED SCEPTOR & SCEPTOR EXCHANGE PTCA GUIDE WIRES | Apr 29, 1996 |
| K960657 | SCIMED CHOICE PT EXCHANGE EXTRA SUPPORT PTCA AND LONG TAPER PTCA GUIDE WIRE | Apr 29, 1996 |
| K955869 | SCIMED ENCORE 26 INFLATION DEVICE/ENCORE 30 INFLATION DEVICE | Mar 22, 1996 |
| K953133 | SCIMED DISPATCH CORONARY INFUSION CATHETER | Feb 23, 1996 |
| K953265 | SCIMED ANGIOGRAPHIC KITS | Jan 16, 1996 |
Scimed Life Systems, Inc. and the FDA: common questions
Has Scimed Life Systems, Inc. received an FDA warning letter?
No FDA warning letter addressed to the name "Scimed Life Systems, Inc." is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.
Has Scimed Life Systems, Inc. received an FDA Form 483?
FDA has not published a Form 483 for "Scimed Life Systems, Inc." in its reading room. FDA publishes some Form 483s, not all of them.
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