The following data is part of a premarket notification filed by Target Therapeutics with the FDA for Target Therapeutics Tracker Lf Catheter.
Device ID | K894105 |
510k Number | K894105 |
Device Name: | TARGET THERAPEUTICS TRACKER LF CATHETER |
Classification | Catheter, Percutaneous |
Applicant | TARGET THERAPEUTICS 130 RIO ROBLES P.O. BOX 610458 San Jose, CA 95134 |
Contact | Marie Daniels |
Correspondent | Marie Daniels TARGET THERAPEUTICS 130 RIO ROBLES P.O. BOX 610458 San Jose, CA 95134 |
Product Code | DQY |
CFR Regulation Number | 870.1250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-06-09 |
Decision Date | 1989-09-28 |