# K861847: Acs Rotating Hemo Valve - Dual Access Type

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Cardiovascular Systems, Inc.
- Decided: Jun 16, 1986 after 34 days
- Product code: LOX (Catheters, Transluminal Coronary Angioplasty, Percutaneous)
- Device class: 2
- Regulation: 21 CFR 870.5100
- Recalls of this device: 2 (0 Class I)
- 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. FDA has not posted a summary or statement for it, so its predicates are not known.

## Recalls of this device
- Dec 5, 2006 · Not classified · Z-0390-2007: Specific lots of the .096' and .115' Rotating Hemostatic Valves (RHV) and the Duostat .096' Rotating Hemostatic Valve (RHV) potentially have an incomplete seal in the packaging pouch
- Dec 5, 2006 · Not classified · Z-0391-2007: Specific lots of the .096' and .115' Rotating Hemostatic Valves (RHV) and the Duostat .096' Rotating Hemostatic Valve (RHV) potentially have an incomplete seal in the packaging pouch

Source page: https://510kreport.com/device/K861847
Methodology: https://510kreport.com/methodology