The following data is part of a premarket notification filed by Scimed Life Systems, Inc. with the FDA for Scimed 6 French Angiographic Catheter Modification.
Device ID | K934541 |
510k Number | K934541 |
Device Name: | SCIMED 6 FRENCH ANGIOGRAPHIC CATHETER MODIFICATION |
Classification | Catheter, Intravascular, Diagnostic |
Applicant | SCIMED LIFE SYSTEMS, INC. 2010 EAST CENTER CIRCLE Plymouth, MN 55441 -2644 |
Contact | Deborah L Jensen |
Correspondent | Deborah L Jensen SCIMED LIFE SYSTEMS, INC. 2010 EAST CENTER CIRCLE Plymouth, MN 55441 -2644 |
Product Code | DQO |
CFR Regulation Number | 870.1200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-09-16 |
Decision Date | 1994-05-12 |