The following data is part of a premarket notification filed by Scimed Life Systems, Inc. with the FDA for Luge Guide Wire.
| Device ID | K973945 |
| 510k Number | K973945 |
| Device Name: | LUGE GUIDE WIRE |
| Classification | Wire, Guide, Catheter |
| Applicant | SCIMED LIFE SYSTEMS, INC. ONE SCIMED PLACE Maple Grove, MN 55311 -1566 |
| Contact | Jill Townsend |
| Correspondent | Jill Townsend 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 | 1997-10-16 |
| Decision Date | 1998-01-12 |
| Summary: | summary |