# K031398: IS-1 Hemostasis Valve, Model 6799

- Pathway: 510(k) (Special)
- Applicant: Guidant Corp.
- Decided: May 20, 2003 after 15 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

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

Source page: https://510kreport.com/device/K031398
Methodology: https://510kreport.com/methodology