The following data is part of a premarket notification filed by Scimed Life Systems, Inc. with the FDA for Scimed 7 Fr. & 8 Fr..
| Device ID | K913364 |
| 510k Number | K913364 |
| Device Name: | SCIMED 7 FR. & 8 FR. |
| Classification | Catheter, Intravascular, Diagnostic |
| Applicant | SCIMED LIFE SYSTEMS, INC. 6655 WEDGWOOD RD. Maple Grove, MN 55369 |
| Contact | Mercedes P Bayani |
| Correspondent | Mercedes P Bayani 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 | 1991-07-29 |
| Decision Date | 1991-08-30 |