The following data is part of a premarket notification filed by Target Therapeutics with the FDA for Guglielmi Detachable Coil (gdc), Fibered Platinum Coil, .035 Type, Berenstein Liquid Coil, Fibered Platinum Coils, Acce.
| Device ID | K971395 |
| 510k Number | K971395 |
| Device Name: | GUGLIELMI DETACHABLE COIL (GDC), FIBERED PLATINUM COIL, .035 TYPE, BERENSTEIN LIQUID COIL, FIBERED PLATINUM COILS, ACCE |
| Classification | Wire, Guide, Catheter |
| Applicant | TARGET THERAPEUTICS 47201 LAKEVIEW DR. Freemont, CA 94538 -6530 |
| Contact | Roxane K Baxter |
| Correspondent | Roxane K Baxter TARGET THERAPEUTICS 47201 LAKEVIEW DR. Freemont, CA 94538 -6530 |
| Product Code | DQX |
| Subsequent Product Code | DQO |
| Subsequent Product Code | DYG |
| Subsequent Product Code | HCG |
| Subsequent Product Code | KRD |
| Subsequent Product Code | LIT |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-04-15 |
| Decision Date | 1997-07-14 |
| Summary: | summary |