# K993057: MBA

- Pathway: 510(k) (Special)
- Applicant: Merit Medical Systems, Inc.
- Decided: Oct 5, 1999 after 22 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 1.

## Indications for use
The MBA Hemostasis Valves are designed for use during percutaneous transluminal angioplasty (PTA) and other intravascular therapeutic procedures that utilize a guiding catheter.

Source page: https://510kreport.com/device/K993057
Methodology: https://510kreport.com/methodology