The following data is part of a premarket notification filed by Bard Peripheral Vascular, Inc. with the FDA for Ultrascore Focused Force Pta Balloon.
| Device ID | K163420 |
| 510k Number | K163420 |
| Device Name: | UltraScore Focused Force PTA Balloon |
| Classification | Catheter, Percutaneous, Cutting/scoring |
| Applicant | BARD PERIPHERAL VASCULAR, INC. 1625 WEST 3RD ST Tempe, AZ 85281 |
| Contact | Timothy Wade |
| Correspondent | Timothy Wade BARD PERIPHERAL VASCULAR, INC. 1625 WEST 3RD ST Tempe, AZ 85281 |
| Product Code | PNO |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-12-06 |
| Decision Date | 2017-06-14 |
| Summary: | summary |