The following data is part of a premarket notification filed by Target Therapeutics with the FDA for Balt Guiding Catheter.
Device ID | K925632 |
510k Number | K925632 |
Device Name: | BALT GUIDING CATHETER |
Classification | Catheter, Intravascular, Diagnostic |
Applicant | TARGET THERAPEUTICS 47201 LAKEVIEW BLVD. P.O. BOX 5120 Freemont, CA 94538 |
Contact | Grace Carland |
Correspondent | Grace Carland TARGET THERAPEUTICS 47201 LAKEVIEW BLVD. P.O. BOX 5120 Freemont, CA 94538 |
Product Code | DQO |
CFR Regulation Number | 870.1200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-11-09 |
Decision Date | 1993-06-29 |
Summary: | summary |