The following data is part of a premarket notification filed by Boston Scientific, Target with the FDA for Matrix Detachable Coils.
| Device ID | K012985 |
| 510k Number | K012985 |
| Device Name: | MATRIX DETACHABLE COILS |
| Classification | Device, Neurovascular Embolization |
| Applicant | BOSTON SCIENTIFIC, TARGET 47900 BAYSIDE PKWY. Fremont, CA 94538 |
| Contact | Seth A Schulman |
| Correspondent | Seth A Schulman 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 | 2001-09-06 |
| Decision Date | 2002-01-31 |
| Summary: | summary |