510(k) K143429
K143429 is an FDA 510(k) premarket notification submitted by Merit Medical Systems, Inc. for the device "Passage Hemostasis Valve". The FDA issued a decision of Substantially Equivalent on December 22, 2014. The device falls under product code DTL (Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4290. Merit Medical Systems, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 22, 2014
- Date Received
- December 1, 2014
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
- Device Class
- Class II
- Regulation Number
- 870.4290
- Review Panel
- CV
- Submission Type