Submission Details
| 510(k) Number | K193119 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 12, 2019 |
| Decision Date | June 29, 2020 |
| Days to Decision | 230 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Traditional
Twin-Pass Dual Access Catheter
Jun 2020
Decision
230d
Days
Class 2
Risk
About This 510(k) Submission
K193119 is an FDA 510(k) clearance for the Twin-Pass Dual Access 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 June 29, 2020, 230 days after receiving the submission on November 12, 2019. 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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