The following data is part of a premarket notification filed by Guidant Corp. with the FDA for Rx Accunet 2 Embolic Protection System.
| Device ID | K042908 |
| 510k Number | K042908 |
| Device Name: | RX ACCUNET 2 EMBOLIC PROTECTION SYSTEM |
| Classification | Temporary Carotid Catheter For Embolic Capture |
| Applicant | GUIDANT CORP. 3200 LAKESIDE DR. Santa Clara, CA 95054 -2807 |
| Contact | Virginia Singer |
| Correspondent | Virginia Singer GUIDANT CORP. 3200 LAKESIDE DR. Santa Clara, CA 95054 -2807 |
| Product Code | NTE |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-10-21 |
| Decision Date | 2004-11-12 |
| Summary: | summary |