Submission Details
| 510(k) Number | K221470 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 20, 2022 |
| Decision Date | June 17, 2022 |
| Days to Decision | 28 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Special
Langston dual lumen catheter
Jun 2022
Decision
28d
Days
Class 2
Risk
About This 510(k) Submission
K221470 is an FDA 510(k) clearance for the Langston dual lumen catheter, a Catheter, Intravascular, Diagnostic (Class II — Special Controls, product code DQO), submitted by Vascular Solutions, LLC (Maple Grove, US). The FDA issued a Cleared decision on June 17, 2022, 28 days after receiving the submission on May 20, 2022. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1200.
Device Classification
| Product Code | DQO — Catheter, Intravascular, Diagnostic |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.1200 |
Manufacturer
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