The following data is part of a premarket notification filed by Target Therapeutics with the FDA for Retrieval Device.
Device ID | K914067 |
510k Number | K914067 |
Device Name: | RETRIEVAL DEVICE |
Classification | Catheter, Intravascular, Diagnostic |
Applicant | TARGET THERAPEUTICS 130 RIO ROBLES P.O. BOX 610458 San Jose, CA 95134 |
Contact | Laura Andeen |
Correspondent | Laura Andeen TARGET THERAPEUTICS 130 RIO ROBLES P.O. BOX 610458 San Jose, CA 95134 |
Product Code | DQO |
CFR Regulation Number | 870.1200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-09-11 |
Decision Date | 1991-12-10 |