The following data is part of a premarket notification filed by Boston Scientific Corp. with the FDA for Matrix Stretch Resistant (sr) Coils.
| Device ID | K050700 |
| 510k Number | K050700 |
| Device Name: | MATRIX STRETCH RESISTANT (SR) COILS |
| 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 | 2005-03-18 |
| Decision Date | 2005-04-15 |
| Summary: | summary |