# K021282: LV-1 Hemostasis Valve, Model #6789

- Pathway: 510(k) (Traditional)
- Applicant: Guidant Corp.
- Decided: May 2, 2002 after 14 days
- Product code: DTL (Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4290
- Recalls of this device: none
- 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.

## Indications for use
The LV-1 Hemostasis Valve with the Wire Guide is indicated for maintaining a seal around the LV-1 lead terminal pin while flushing the lead lumen and/or during introduction/withdrawal of interventional devices.

Source page: https://510kreport.com/device/K021282
Methodology: https://510kreport.com/methodology