The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Rx Accunet Lp Embolic Protection System.
| Device ID | K081549 |
| 510k Number | K081549 |
| Device Name: | RX ACCUNET LP EMBOLIC PROTECTION SYSTEM |
| Classification | Temporary Carotid Catheter For Embolic Capture |
| Applicant | ABBOTT LABORATORIES 3200 Lakeside Drive Santa Clara, CA 95054 |
| Contact | Virginia Singer |
| Correspondent | Virginia Singer ABBOTT LABORATORIES 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 | 2008-06-03 |
| Decision Date | 2008-08-19 |
| Summary: | summary |