# K172453: WATCHDOG Hemostasis Valve Kit

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corporation
- Decided: Nov 9, 2017 after 87 days
- Product code: DQX (Wire, Guide, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1330
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K854261 (1985). 12 ancestors in all.
No later device cites it as a predicate yet.
2 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122301: Guardian II Hemostasis Valve Guardian II NC Hemostasis Valve, Vascular Solutions Zerusa, Ltd. (2012) Summary page 5.
- K140673: Insertion Tool, Boston Scientific Corp (2014) Summary page 5.

## Recalls of this device
- Apr 5, 2023 · Class II · Z-1592-2023: The firm received complaints of the Insertion Tool component being occluded, resulting in the inability to pass a guidewire through the tool.
- Apr 5, 2023 · Class II · Z-1593-2023: The firm received complaints of the Insertion Tool component being occluded, resulting in the inability to pass a guidewire through the tool.

## Indications for use
The WATCHDOG™ Hemostasis Valve is intended to maintain hemostasis during diagnostic/ interventional procedures. The WATCHDOG™ Hemostasis Valve is indicated for maintaining a seal around diagnostic/ interventional devices with combined outer diameters of up to 8F [0.105 in (2.67 mm)] during diagnostic/ interventional procedures. The Insertion Tool is used to facilitate the introduction of a guidewire during general intravascular procedures. The Torque Device is used for guidewire manipulation during general intravascular procedures.

Source page: https://510kreport.com/device/K172453
Methodology: https://510kreport.com/methodology