The following data is part of a premarket notification filed by Abbott Vascular with the FDA for Emboshield Nav6 Embolic Protection System.
| Device ID | K121015 |
| 510k Number | K121015 |
| Device Name: | EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM |
| Classification | Temporary Carotid Catheter For Embolic Capture |
| Applicant | Abbott Vascular 3200 Lakeside Drive Santa Clara, CA 95054 |
| Contact | Ivalee Cohen |
| Correspondent | Ivalee Cohen Abbott Vascular 3200 Lakeside Drive Santa Clara, CA 95054 |
| Product Code | NTE |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-04-04 |
| Decision Date | 2012-05-04 |
| Summary: | summary |