# K143429: Passage Hemostasis Valve

- Pathway: 510(k) (Special)
- Applicant: Merit Medical Systems, Inc.
- Decided: Dec 22, 2014 after 21 days
- Product code: DTL (Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4290
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K925419 (1993). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K925419: Passage Hemostasis Valve, Merit Medical Systems, Inc. (1993) Summary page 4.

## Indications for use
The Passage Hemostasis Valve is recommended for maintaining a fluid-tight seal around percutaneous transluminal angioplasty catheters and guidewires.

Source page: https://510kreport.com/device/K143429
Methodology: https://510kreport.com/methodology