The following data is part of a premarket notification filed by Boston Scientific, Target with the FDA for Gdc Ultrasoft Coil.
| Device ID | K002181 |
| 510k Number | K002181 |
| Device Name: | GDC ULTRASOFT COIL |
| Classification | Device, Neurovascular Embolization |
| Applicant | BOSTON SCIENTIFIC, TARGET 47900 BAYSIDE PKWY. Fremont, CA 94538 |
| Contact | James Leathley |
| Correspondent | James Leathley BOSTON SCIENTIFIC, TARGET 47900 BAYSIDE PKWY. Fremont, CA 94538 |
| Product Code | HCG |
| CFR Regulation Number | 882.5950 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-07-19 |
| Decision Date | 2000-08-11 |