# K031688: Rapido Cut-a-Way Rotating Hemostasis Valve

- Pathway: 510(k) (Special)
- Applicant: Guidant Corporation
- Decided: Jul 2, 2003 after 30 days
- Product code: DTL (Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4290
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K854261 (1985). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K854261: Advanced Cardiovascular Systems Hemostatic Valves, Advanced Cardiovascular Systems, Inc. (1985) Summary page 1.

## Most influential descendants
- K052459: 6248VAL Adjustable Valve (2006), 0 descendants of its own

## Recalls of this device
- Jan 7, 2011 · Not classified · Z-2793-2011: Five lots of Guide Catheters and Accessory products were processed through Ethylene Oxide (ETO) sterilization with additional plastic material covering the pallet, which is not consistent with validat

## Indications for use
The Rotating Hemostasis Valve is intended for maintaining a fluid-tight seal around devices, including implantable coronary venous leads, during the implant procedure.

Source page: https://510kreport.com/device/K031688
Methodology: https://510kreport.com/methodology