The following data is part of a premarket notification filed by Abbott Vascular with the FDA for Emboshield Nav6 Embolic Protection System, Barewire Filter Delivery Wires.
| Device ID | K191173 |
| 510k Number | K191173 |
| Device Name: | Emboshield NAV6 Embolic Protection System, Barewire Filter Delivery Wires |
| Classification | Temporary Carotid Catheter For Embolic Capture |
| Applicant | Abbott Vascular 3200 Lakeside Drive Santa Clara, CA 95054 |
| Contact | Namratha Manthani |
| Correspondent | Namratha Manthani Abbott Vascular 3200 Lakeside Drive Santa Clara, CA 95054 |
| Product Code | NTE |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-05-01 |
| Decision Date | 2019-07-25 |
| Summary: | summary |