The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Emboshield Nav6 Embolic Protection System, Barewire Filter Delivery Wire-workhorse-190cm / 315cm, Barewire Filter Del...
| Device ID | K110909 |
| 510k Number | K110909 |
| Device Name: | EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM, BAREWIRE FILTER DELIVERY WIRE-WORKHORSE-190CM / 315CM, BAREWIRE FILTER DEL.. |
| Classification | Temporary Carotid Catheter For Embolic Capture |
| Applicant | ABBOTT LABORATORIES 3200 Lakeside Drive Santa Clara, CA 95054 |
| Contact | Cherece L Jones |
| Correspondent | Cherece L Jones ABBOTT LABORATORIES 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 | 2011-03-31 |
| Decision Date | 2011-04-29 |
| Summary: | summary |