Langston dual lumen catheter
FDA 510(k) K221470 · Vascular Solutions, LLC
510(k) numberK221470
Submission
- Device name
- Langston dual lumen catheter
- Applicant
- Vascular Solutions, LLC
Minneapolis, MN, US - Received
- May 20, 2022
- Decision date
- June 17, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DQO – Catheter, Intravascular, Diagnostic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1200
- Specialty
- Cardiovascular
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Questions and answers
When was Langston dual lumen catheter cleared by the FDA?
Langston dual lumen catheter (K221470) received a 510(k) decision of Substantially Equivalent on June 17, 2022, 28 days after the submission was received.
What is the product code of K221470?
The FDA product code is DQO – Catheter, Intravascular, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 870.1200.