# K955554: Hemo-Valve

- Pathway: 510(k) (Traditional)
- Applicant: North American Instrument Corp.
- Decided: Mar 4, 1996 after 90 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) NAMIC High Pressure Stopcock: named in the summary without a submission number
- (no number) NAMIC PTCA Y-Adaptor: named in the summary without a submission number
- (no number) Braun Safsite Valve: named in the summary without a submission number

## Indications for use
The HEMO-Valve is recommended for use in angiographic procedures involving blood or other potentially infectious materials, so that the procedure can be performed in such a manner as to minimize blood loss and patient/user exposure to these substances. The HEMO-Valve is intended for use in intra-arterial and intravenous administration of fluids, including radiographic contrast media.

Source page: https://510kreport.com/device/K955554
Methodology: https://510kreport.com/methodology