The following data is part of a premarket notification filed by Scimed Life Systems, Inc. with the FDA for Scimed Choice Pt Ptca Guide Wire.
| Device ID | K950835 |
| 510k Number | K950835 |
| Device Name: | SCIMED CHOICE PT PTCA GUIDE WIRE |
| Classification | Wire, Guide, Catheter |
| Applicant | SCIMED LIFE SYSTEMS, INC. ONE SCIMED PLACE Maple Grove, MN 55311 |
| Contact | Deborah L Jensen |
| Correspondent | Deborah L Jensen SCIMED LIFE SYSTEMS, INC. ONE SCIMED PLACE Maple Grove, MN 55311 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-02-24 |
| Decision Date | 1995-05-25 |