The following data is part of a premarket notification filed by Target Therapeutics with the FDA for Fibered Platinum Coil, .035 Type.
| Device ID | K955293 |
| 510k Number | K955293 |
| Device Name: | FIBERED PLATINUM COIL, .035 TYPE |
| Classification | Device, Vascular, For Promoting Embolization |
| Applicant | TARGET THERAPEUTICS 47201 LAKEVIEW BLVD. P.O. BOX 5120 Freemont, CA 94538 |
| Contact | Laraine Pangelina |
| Correspondent | Laraine Pangelina TARGET THERAPEUTICS 47201 LAKEVIEW BLVD. P.O. BOX 5120 Freemont, CA 94538 |
| Product Code | KRD |
| CFR Regulation Number | 870.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-11-16 |
| Decision Date | 1996-02-06 |