The following data is part of a premarket notification filed by Angioscore, Inc. with the FDA for Modification To Angiosculpt Pta Scoring Balloon Catheter.
Device ID | K081220 |
510k Number | K081220 |
Device Name: | MODIFICATION TO ANGIOSCULPT PTA SCORING BALLOON CATHETER |
Classification | Catheter, Percutaneous, Cutting/scoring |
Applicant | ANGIOSCORE, INC. 5055 BRANDIN COURT Fremont, CA 94538 |
Contact | Kimberley Kline |
Correspondent | Kimberley Kline ANGIOSCORE, INC. 5055 BRANDIN COURT Fremont, CA 94538 |
Product Code | PNO |
CFR Regulation Number | 870.1250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2008-04-30 |
Decision Date | 2008-05-28 |
Summary: | summary |