The following data is part of a premarket notification filed by W. L. Gore & Associates, Inc. with the FDA for Gore Flow Reversal System Model Gfrs073.
| Device ID | K123156 |
| 510k Number | K123156 |
| Device Name: | GORE FLOW REVERSAL SYSTEM MODEL GFRS073 |
| Classification | Temporary Carotid Catheter For Embolic Capture |
| Applicant | W. L. GORE & ASSOCIATES, INC. 32360 N NORTH VALLEY PARKWAY Phoenix, AZ 85085 |
| Contact | Sharon Alexander |
| Correspondent | Sharon Alexander W. L. GORE & ASSOCIATES, INC. 32360 N NORTH VALLEY PARKWAY Phoenix, AZ 85085 |
| Product Code | NTE |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-10-09 |
| Decision Date | 2012-12-13 |
| Summary: | summary |