The following data is part of a premarket notification filed by Abbott Vascular with the FDA for Rx Accunet Embolic Protection System.
| Device ID | K153086 |
| 510k Number | K153086 |
| Device Name: | RX ACCUNET Embolic Protection System |
| Classification | Temporary Carotid Catheter For Embolic Capture |
| Applicant | ABBOTT VASCULAR 3200, LAKESIDE DRIVE Santa Clara, CA 95054 |
| Contact | Aruna Akkapeddi |
| Correspondent | Aruna Akkapeddi 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 | 2015-10-26 |
| Decision Date | 2015-11-20 |
| Summary: | summary |