The following data is part of a premarket notification filed by Boston Scientific Corp. with the FDA for Gdc-10 360 Degree Coil Sr; Gdc-10 360 Degree Soft Coil Sr; Gdc-18 360 Degree Coil.
| Device ID | K042539 |
| 510k Number | K042539 |
| Device Name: | GDC-10 360 DEGREE COIL SR; GDC-10 360 DEGREE SOFT COIL SR; GDC-18 360 DEGREE COIL |
| Classification | Device, Neurovascular Embolization |
| Applicant | BOSTON SCIENTIFIC CORP. 47900 BAYSIDE PARKWAY Fremont, CA 94538 -6515 |
| Contact | James Leathley |
| Correspondent | James Leathley BOSTON SCIENTIFIC CORP. 47900 BAYSIDE PARKWAY Fremont, CA 94538 -6515 |
| Product Code | HCG |
| CFR Regulation Number | 882.5950 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-09-20 |
| Decision Date | 2004-10-19 |
| Summary: | summary |