# K031903: Rapido Cut-Away Bleedback Control Valve (BBCV), Model 7568

- Pathway: 510(k) (Traditional)
- Applicant: Guidant Corporation
- Decided: Mar 3, 2004 after 257 days
- Product code: DTZ (Oxygenator, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4350
- 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: 2 generations back to K854261 (1985). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991102: Copilot Bleedback Control Valve, Model 1003331, Guidant Corp. (1999) Summary page 1.

## 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 Guidant Bleedback Control Valve is intended for maintaining a seal around diagnostic/interventional devices with an outside diameter of less than 0.185" in the venous anatomy only, during interventional procedures.

Source page: https://510kreport.com/device/K031903
Methodology: https://510kreport.com/methodology