The following data is part of a premarket notification filed by Scimed Life Systems, Inc. with the FDA for Scimed Sceptor & Sceptor Exchange Ptca Guide Wires.
| Device ID | K960563 |
| 510k Number | K960563 |
| Device Name: | SCIMED SCEPTOR & SCEPTOR EXCHANGE PTCA GUIDE WIRES |
| Classification | Wire, Guide, Catheter |
| Applicant | SCIMED LIFE SYSTEMS, INC. ONE SCIMED PLACE Maple Grove, MN 55311 -1566 |
| Contact | Connie J Del Toro |
| Correspondent | Connie J Del Toro SCIMED LIFE SYSTEMS, INC. ONE SCIMED PLACE Maple Grove, MN 55311 -1566 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-02-09 |
| Decision Date | 1996-04-29 |
| Summary: | summary |