The following data is part of a premarket notification filed by Scimed Life Systems, Inc. with the FDA for Scimed 6f Angiographic Catheter.
Device ID | K932542 |
510k Number | K932542 |
Device Name: | SCIMED 6F ANGIOGRAPHIC CATHETER |
Classification | Catheter, Intravascular, Diagnostic |
Applicant | SCIMED LIFE SYSTEMS, INC. 6655 WEDGWOOD RD. Maple Grove, MN 55311 -3616 |
Contact | Darlene Thometz |
Correspondent | Darlene Thometz SCIMED LIFE SYSTEMS, INC. 6655 WEDGWOOD RD. Maple Grove, MN 55311 -3616 |
Product Code | DQO |
CFR Regulation Number | 870.1200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-05-26 |
Decision Date | 1993-08-11 |