The following data is part of a premarket notification filed by W.l. Gore & Associates,inc with the FDA for Gore Flow Reversal System.
| Device ID | K083300 |
| 510k Number | K083300 |
| Device Name: | GORE FLOW REVERSAL SYSTEM |
| Classification | Temporary Carotid Catheter For Embolic Capture |
| Applicant | W.L. GORE & ASSOCIATES,INC 3250 W. KILTIE LANE Flagstaff, AZ 86005 |
| Contact | Michelle A Wells |
| Correspondent | Michelle A Wells W.L. GORE & ASSOCIATES,INC 3250 W. KILTIE LANE Flagstaff, AZ 86005 |
| Product Code | NTE |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-11-10 |
| Decision Date | 2009-02-04 |
| Summary: | summary |