The following data is part of a premarket notification filed by Guidant Corporation with the FDA for Rx Accunet Embolic Protection System.
Device ID | K052165 |
510k Number | K052165 |
Device Name: | 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 | 2005-08-16 |
Summary: | summary |