The following data is part of a premarket notification filed by Target Therapeutics with the FDA for Helix Shaped Coils With Dacron Fibers, Modified.
| Device ID | K913312 |
| 510k Number | K913312 |
| Device Name: | HELIX SHAPED COILS WITH DACRON FIBERS, MODIFIED |
| Classification | Device, Neurovascular Embolization |
| Applicant | TARGET THERAPEUTICS 130 RIO ROBLES P.O. BOX 610458 San Jose, CA 95134 |
| Contact | Lloyd H Griese |
| Correspondent | Lloyd H Griese TARGET THERAPEUTICS 130 RIO ROBLES P.O. BOX 610458 San Jose, CA 95134 |
| Product Code | HCG |
| CFR Regulation Number | 882.5950 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-07-25 |
| Decision Date | 1991-11-08 |