Submission Details
| 510(k) Number | K191560 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 13, 2019 |
| Decision Date | August 09, 2019 |
| Days to Decision | 57 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Traditional
Turnpike Catheter; Turnpike Spiral Catheter; Turnpike Gold Catheter; Turnpike LP Catheter
Aug 2019
Decision
57d
Days
Class 2
Risk
About This 510(k) Submission
K191560 is an FDA 510(k) clearance for the Turnpike Catheter; Turnpike Spiral Catheter; Turnpike Gold Catheter; Turnpike LP 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 August 9, 2019, 57 days after receiving the submission on June 13, 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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