The following data is part of a premarket notification filed by Target Therapeutics with the FDA for Target Therapeutics Coils.
Device ID | K914786 |
510k Number | K914786 |
Device Name: | TARGET THERAPEUTICS COILS |
Classification | Device, Vascular, For Promoting Embolization |
Applicant | TARGET THERAPEUTICS 130 RIO ROBLES P.O. BOX 610458 San Jose, CA 95134 |
Contact | Grace Brors |
Correspondent | Grace Brors TARGET THERAPEUTICS 130 RIO ROBLES P.O. BOX 610458 San Jose, CA 95134 |
Product Code | KRD |
CFR Regulation Number | 870.3300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-10-23 |
Decision Date | 1992-04-20 |