The following data is part of a premarket notification filed by Bard Peripheral Vascular, Inc. with the FDA for Ultraverse Rx Pta Balloon Dilatation Catheter.
| Device ID | K131199 |
| 510k Number | K131199 |
| Device Name: | ULTRAVERSE RX PTA BALLOON DILATATION CATHETER |
| Classification | Catheter, Angioplasty, Peripheral, Transluminal |
| Applicant | BARD PERIPHERAL VASCULAR, INC. 1625 WEST 3RD ST. Tempe, AZ 85281 |
| Contact | Mario Thomas |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | LIT |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2013-04-26 |
| Decision Date | 2013-05-30 |
| Summary: | summary |