The following data is part of a premarket notification filed by W.l. Gore & Associates with the FDA for Gore(r) Embolic Filter.
| Device ID | K120480 |
| 510k Number | K120480 |
| Device Name: | GORE(R) EMBOLIC FILTER |
| Classification | Temporary Carotid Catheter For Embolic Capture |
| Applicant | W.L. GORE & ASSOCIATES 4250 WEST KILTIE LN Flagstaff, AZ 86001 |
| Contact | Michelle Ann Wells |
| Correspondent | Michelle Ann Wells W.L. GORE & ASSOCIATES 4250 WEST KILTIE LN Flagstaff, AZ 86001 |
| Product Code | NTE |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-02-16 |
| Decision Date | 2012-03-16 |
| Summary: | summary |