The following data is part of a premarket notification filed by Scimed Life Systems, Inc. with the FDA for Scimed 6 French Wiseguide Guide Catheter.
| Device ID | K981788 |
| 510k Number | K981788 |
| Device Name: | SCIMED 6 FRENCH WISEGUIDE GUIDE CATHETER |
| Classification | Catheter, Intravascular, Diagnostic |
| Applicant | SCIMED LIFE SYSTEMS, INC. ONE SCIMED PLACE Maple Grove, MN 55311 -1566 |
| Contact | Melanie Raska |
| Correspondent | Melanie Raska SCIMED LIFE SYSTEMS, INC. ONE SCIMED PLACE Maple Grove, MN 55311 -1566 |
| Product Code | DQO |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-05-20 |
| Decision Date | 1998-08-18 |
| Summary: | summary |