# K991102: Copilot Bleedback Control Valve, Model 1003331

- Pathway: 510(k) (Traditional)
- Applicant: Guidant Corp.
- Decided: Jun 9, 1999 after 69 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.
34 later devices descend from it; 7 cite it directly.
3 of 36 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
- 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
- K092711: Guardian II Hemostasis Valve (2009), 8 descendants of its own

## Recalls of this device
- Jan 7, 2011 · Not classified · Z-2792-2011: 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 COPILOT™ Bleedback Control Valve is indicated for maintaining a seal around diagnostic/interventional devices with an outside diameter < 0.096” during interventional procedures.

Source page: https://510kreport.com/device/K991102
Methodology: https://510kreport.com/methodology