The following data is part of a premarket notification filed by Scimed Life Systems, Inc. with the FDA for Choice Super Support Ptca Guide Wire, Choice Plus Super Support Ptca Guide Wire, Choice Exchange Super Support Ptca Guid.
| Device ID | K964551 |
| 510k Number | K964551 |
| Device Name: | CHOICE SUPER SUPPORT PTCA GUIDE WIRE, CHOICE PLUS SUPER SUPPORT PTCA GUIDE WIRE, CHOICE EXCHANGE SUPER SUPPORT PTCA GUID |
| 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 | 1996-11-13 |
| Decision Date | 1997-05-21 |
| Summary: | summary |