The following data is part of a premarket notification filed by C.r. Bard with the FDA for Ultrascore Focused Force Pta Balloon.
| Device ID | K172571 |
| 510k Number | K172571 |
| Device Name: | ULTRASCORE Focused Force PTA Balloon |
| Classification | Catheter, Percutaneous, Cutting/scoring |
| Applicant | C.R. Bard 1625 W 3rd St Tempe, AZ 85281 |
| Contact | Jonathan Holmes |
| Correspondent | Jonathan Holmes C.R. Bard 1625 W 3rd St Tempe, AZ 85281 |
| Product Code | PNO |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-08-28 |
| Decision Date | 2017-09-22 |
| Summary: | summary |