# K122301: Guardian II Hemostasis Valve Guardian II NC Hemostasis Valve

- Pathway: 510(k) (Traditional)
- Applicant: Vascular Solutions Zerusa, Ltd.
- Decided: Sep 7, 2012 after 37 days
- Product code: DTL (Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4290
- Recalls of this device: 2 (2 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K854261 (1985). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
2 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092711: Guardian II Hemostasis Valve, Zerusa Limited (2009) Summary page 1.

## Cited in the summary but kept off the family tree
- K100113: Vanguard Breast Mri Auxiliary Table with 16 Channel Coil Array for GE 3T Mri System, Model 4000451-51, Sentinelle Medical, Inc. (2010). Our reading of the summary gave K100113, FDA’s number for Vanguard Breast Mri Auxiliary Table with 16 Channel Coil… (Sentinelle Medical, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Guardian II NC”. Kept off the family tree.

## Most influential descendants
- K172453: WATCHDOG Hemostasis Valve Kit (2017), 0 descendants of its own

## Recalls of this device
- Mar 4, 2016 · Class I · Z-1275-2016: Vascular Solutions became aware of a potential problem with the click version of the Guardian II hemostasis valves. The low pressure seal may not close properly, which may allow air to be introduced i
- Feb 27, 2013 · Class I · Z-0955-2013: Risk that air may be introduced into the device which may lead to an air embolism.

## Indications for use
Guardian hemostasis valves are intended to maintain bemostasis during the use of diagnostic or interventional devices. Guardian bemostasis valves are indicated for maintaining a seal around diagnostic/interventional devices with outside diameters up to 8F (0. 105" or 2.67 mm) during diagnostic/interventional procedures. The torque device is provided as an aid in steering the guidewire within the vascular anatomy.

Source page: https://510kreport.com/device/K122301
Methodology: https://510kreport.com/methodology