The following data is part of a premarket notification filed by Scimed Life Systems, Inc. with the FDA for Scimed 8 French Big-max Guide Catheter.
| Device ID | K943777 |
| 510k Number | K943777 |
| Device Name: | SCIMED 8 FRENCH BIG-MAX GUIDE CATHETER |
| Classification | Catheter, Percutaneous |
| Applicant | SCIMED LIFE SYSTEMS, INC. 8200 SCIMED PLACE Maple Grove, MN 55311 -1566 |
| Contact | Diane M Lowe |
| Correspondent | Diane M Lowe SCIMED LIFE SYSTEMS, INC. 8200 SCIMED PLACE Maple Grove, MN 55311 -1566 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-08-02 |
| Decision Date | 1994-10-13 |