The following data is part of a premarket notification filed by Angioscore, Inc. with the FDA for Angiosculpt Pta Scoring Balloon Catheter Model 2039-xxyy, 2076-xxyy, 2092-xxyy, 2105-xxyy.
| Device ID | K100303 |
| 510k Number | K100303 |
| Device Name: | ANGIOSCULPT PTA SCORING BALLOON CATHETER MODEL 2039-XXYY, 2076-XXYY, 2092-XXYY, 2105-XXYY |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-02-03 |
| Decision Date | 2010-03-22 |
| Summary: | summary |