The following data is part of a premarket notification filed by Scimed Life Systems, Inc. with the FDA for Scimed Coronary Guiding Catheter.
| Device ID | K895437 |
| 510k Number | K895437 |
| Device Name: | SCIMED CORONARY GUIDING CATHETER |
| Classification | Catheter, Intravascular, Diagnostic |
| Applicant | SCIMED LIFE SYSTEMS, INC. 6655 WEDGWOOD RD. Maple Grove, MN 55369 |
| Contact | Darlene A Thometz |
| Correspondent | Darlene A Thometz SCIMED LIFE SYSTEMS, INC. 6655 WEDGWOOD RD. Maple Grove, MN 55369 |
| Product Code | DQO |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-09-08 |
| Decision Date | 1990-06-28 |