# K153685: Sunmed Haemostatic Valves

- Pathway: 510(k) (Traditional)
- Applicant: Sunny Medical Device (Shenzhen) Co., Ltd.
- Decided: Oct 13, 2016 after 296 days
- Product code: DQX (Wire, Guide, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1330
- 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). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113148: E-PASS, Synexmed (Shenzhen)Company Limited (2012) Summary page 4.
- K131124: Colign, Jilin Coronado Medical, Ltd. (2013) Summary page 5.

## Indications for use
The SunmedTM Haemostatic Valves is intended to maintain hemostasis during the introduction/withdrawal and use of diagnostic and interventional devices up to an external diameter of 7 Fr, 8 Fr or 9 Fr; The insertion tool facilitates introduction of guide wire through the haemostatic valves to reach the guiding catheter; The torquer provides a handle for easier manipulation of the guide wire when inserted into the proximal end of the guide wire.

Source page: https://510kreport.com/device/K153685
Methodology: https://510kreport.com/methodology