# K854261: Advanced Cardiovascular Systems Hemostatic Valves

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Cardiovascular Systems, Inc.
- Decided: Dec 4, 1985 after 42 days
- Product code: DTL (Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4290
- 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.
37 later devices descend from it; 2 cite it directly.
3 of 38 devices 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.

## Most influential descendants
- K991102: Copilot Bleedback Control Valve, Model 1003331 (1999), 34 descendants of its own
- K042060: Easypass US Y-Connector Hemostatic Valve (2004), 17 descendants of its own
- K040498: Myshell (2004), 12 descendants of its own
- K052381: Guardian Hemostasis Valve with Guidewire Introducer (2005), 11 descendants of its own
- K073620: Guardian Hemostasis Valve (2008), 10 descendants of its own

## 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/K854261
Methodology: https://510kreport.com/methodology