Merit Marquis Flow Switch
FDA 510(k) K110643 · Merit Medical Systems, Inc.
510(k) numberK110643
Submission
- Device name
- Merit Marquis Flow Switch
- Applicant
- Merit Medical Systems, Inc.
Galway, IE - Received
- March 4, 2011
- Decision date
- July 1, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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 Merit Marquis Flow Switch cleared by the FDA?
Merit Marquis Flow Switch (K110643) received a 510(k) decision of Substantially Equivalent on July 1, 2011, 119 days after the submission was received.
What is the product code of K110643?
The FDA product code is DQO – Catheter, Intravascular, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 870.1200.