K131199 is an FDA 510(k) clearance for the ULTRAVERSE RX PTA BALLOON DILATATION CATHETER. This device is classified as a Catheter, Angioplasty, Peripheral, Transluminal (Class II - Special Controls, product code LIT).
Submitted by Bard Peripheral Vascular, Inc. (Tempe, US). The FDA issued a Cleared decision on May 30, 2013, 34 days after receiving the submission on April 26, 2013.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1250.
| 510(k) Number | K131199 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 26, 2013 |
| Decision Date | May 30, 2013 |
| Days to Decision | 34 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | LIT — Catheter, Angioplasty, Peripheral, Transluminal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1250 |