The following data is part of a premarket notification filed by Target Therapeutics with the FDA for Fasguide.
Device ID | K951159 |
510k Number | K951159 |
Device Name: | FASGUIDE |
Classification | Catheter, Percutaneous |
Applicant | TARGET THERAPEUTICS 47201 LAKEVIEW BLVD. P.O. BOX 5120 Freemont, CA 94538 |
Contact | Laraine Pangelina |
Correspondent | Laraine Pangelina TARGET THERAPEUTICS 47201 LAKEVIEW BLVD. P.O. BOX 5120 Freemont, CA 94538 |
Product Code | DQY |
CFR Regulation Number | 870.1250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-03-14 |
Decision Date | 1995-09-25 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() FASGUIDE 74433711 1906421 Dead/Cancelled |
TARGET THERAPEUTICS, INC. 1993-09-03 |