The following data is part of a premarket notification filed by Angioscore, Inc. with the FDA for Angiosculpt Pta Scoring Balloon Catheter.
| Device ID | K110767 |
| 510k Number | K110767 |
| Device Name: | ANGIOSCULPT PTA SCORING BALLOON CATHETER |
| Classification | Catheter, Percutaneous, Cutting/scoring |
| Applicant | ANGIOSCORE, INC. 555 THIRTEENTH STREET NW Washington, DC 20004 |
| Contact | Jonathan S Kahan |
| Correspondent | Jonathan S Kahan ANGIOSCORE, INC. 555 THIRTEENTH STREET NW Washington, DC 20004 |
| Product Code | PNO |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-03-18 |
| Decision Date | 2011-04-15 |
| Summary: | summary |