# K131411: Coseal

- Pathway: 510(k) (Traditional)
- Applicant: Jilin Coronado Medical, Ltd.
- Decided: Sep 26, 2013 after 134 days
- Product code: DXC (Clamp, Vascular)
- Device class: 2
- Regulation: 21 CFR 870.4450
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K062569 (2007). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070423: TR Band, Terumo Medical Corp. (2007) Summary page 1.
- K122405: Air-Band Radial Compression Device, Datascope Corp., Cardiac Assist Division (2012) Summary page 1.

## Indications for use
The CoSeali Arterial Compression Band is acompression device that indicated to assist hemostasis of the radial artery after a transradial procedure. the device is designed to compress the radial artery puncture site while maintaining site visibility and a secure fit around the wrist, minimizing the loss of blood.

Source page: https://510kreport.com/device/K131411
Methodology: https://510kreport.com/methodology