The following data is part of a premarket notification filed by W.l. Gore & Associates,inc with the FDA for Gore Embolic Filter.
| Device ID | K103500 |
| 510k Number | K103500 |
| Device Name: | GORE EMBOLIC FILTER |
| Classification | Temporary Carotid Catheter For Embolic Capture |
| Applicant | W.L. GORE & ASSOCIATES,INC 4250 WEST KILTIE LANE Flagstaff, AZ 86001 |
| Contact | Michelle A Wells |
| Correspondent | Michelle A Wells W.L. GORE & ASSOCIATES,INC 4250 WEST KILTIE LANE Flagstaff, AZ 86001 |
| Product Code | NTE |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-11-29 |
| Decision Date | 2011-05-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00733132618286 | K103500 | 000 |
| 00733132618279 | K103500 | 000 |
| H373GEFA01530039 | K103500 | 000 |
| 00733132618255 | K103500 | 000 |