# K073620: Guardian Hemostasis Valve

- Pathway: 510(k) (Traditional)
- Applicant: Zerusa Limited
- Decided: Feb 27, 2008 after 63 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: 4 generations back to K854261 (1985). 4 ancestors in all.
10 later devices descend from it; 2 cite it directly.
3 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052381: Guardian Hemostasis Valve with Guidewire Introducer, Zerusa Limited (2005) Summary page 1.

## Most influential descendants
- K092711: Guardian II Hemostasis Valve (2009), 8 descendants of its own
- K100093: Vsi Torque Device (2010), 4 descendants of its own
- K141054: Distal Access Torque Device (2014), 3 descendants of its own
- K170684: Firebow Wire Torque Assist Device (2017), 1 descendant of its own
- K122301: Guardian II Hemostasis Valve Guardian II NC Hemostasis Valve (2012), 1 descendant of its own

## Indications for use
The Guardian HV is intended to maintain hemostasis during the use of diagnostic/interventional devices. The device is indicated for maintaining a seal around diagnostic/interventional devices with outside diameters up to 8.01F (2.67 mm or 0.105") during diagnostic/interventional procedures. The guidewire introducer is included to facilitate the guidewire's passage through the Guardian HV. The Torque device is included to manipulate the steering of the guidewire within the vascular regions.

Source page: https://510kreport.com/device/K073620
Methodology: https://510kreport.com/methodology