The following data is part of a premarket notification filed by Guidant Corporation with the FDA for Modification To: Rx Accunet Embolic Protection System.
| Device ID | K052166 |
| 510k Number | K052166 |
| Device Name: | MODIFICATION TO: RX ACCUNET EMBOLIC PROTECTION SYSTEM |
| Classification | Temporary Carotid Catheter For Embolic Capture |
| Applicant | GUIDANT CORPORATION 3200 Lakeside Drive Santa Clara, CA 95054 |
| Contact | Julia Anastas |
| Correspondent | Julia Anastas GUIDANT CORPORATION 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 | 2005-08-09 |
| Decision Date | 2005-08-18 |
| Summary: | summary |