The following data is part of a premarket notification filed by Angioscore, Inc. with the FDA for Angiosculpt Pta Scoring Balloon With Hydrocross Caoting.
| Device ID | K133998 |
| 510k Number | K133998 |
| Device Name: | ANGIOSCULPT PTA SCORING BALLOON WITH HYDROCROSS CAOTING |
| 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 | 2013-12-26 |
| Decision Date | 2014-04-18 |
| Summary: | summary |