Submission Details
| 510(k) Number | K192318 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Traditional
Ultraverse 014 and 018 PTA Balloon Dilatation Catheters
Oct 2019
Decision
38d
Days
Class 2
Risk
About This 510(k) Submission
K192318 is an FDA 510(k) clearance for the Ultraverse 014 and 018 PTA Balloon Dilatation Catheters, 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 review panel. Regulated under 21 CFR 870.1250.
Device Classification
| Product Code | LIT — Catheter, Angioplasty, Peripheral, Transluminal |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.1250 |
Manufacturer
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