K192318 is an FDA 510(k) clearance for the Ultraverse 014 and 018 PTA Balloon Dilatation Catheters. 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 October 3, 2019, 38 days after receiving the submission on August 26, 2019.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1250.
| 510(k) Number | K192318 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 26, 2019 |
| Decision Date | October 03, 2019 |
| Days to Decision | 38 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 |