Submission Details
| 510(k) Number | K182570 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 18, 2018 |
| Decision Date | March 13, 2019 |
| Days to Decision | 176 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Traditional
Venture 0.014 Catheter
Mar 2019
Decision
176d
Days
Class 2
Risk
About This 510(k) Submission
K182570 is an FDA 510(k) clearance for the Venture 0.014 Catheter, a Catheter, Percutaneous (Class II — Special Controls, product code DQY), submitted by Vascular Solutions, LLC (Maple Grove, US). The FDA issued a Cleared decision on March 13, 2019, 176 days after receiving the submission on September 18, 2018. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1250.
Device Classification
| Product Code | DQY — Catheter, Percutaneous |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.1250 |
Manufacturer
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