The following data is part of a premarket notification filed by Boston Scientific, Target with the FDA for Gdc-10 Guglielmi Detachable Coil (gdc) (3d Shape Gdc), Gdc-18 Guglielmi Detachable Coil (gdc) (3d Shape Gdc).
| Device ID | K993417 |
| 510k Number | K993417 |
| Device Name: | GDC-10 GUGLIELMI DETACHABLE COIL (GDC) (3D SHAPE GDC), GDC-18 GUGLIELMI DETACHABLE COIL (GDC) (3D SHAPE GDC) |
| Classification | Device, Neurovascular Embolization |
| Applicant | BOSTON SCIENTIFIC, TARGET 47900 BAYSIDE PKWY. Fremont, CA 94538 |
| Contact | Roxane Baxter |
| Correspondent | Roxane Baxter BOSTON SCIENTIFIC, TARGET 47900 BAYSIDE PKWY. Fremont, CA 94538 |
| Product Code | HCG |
| CFR Regulation Number | 882.5950 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-10-01 |
| Decision Date | 2000-01-21 |
| Summary: | summary |