# K162027: TRAcelet Compression Device

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Vascular
- Decided: Oct 21, 2016 after 91 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: 1 generation back to K070423 (2007). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 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 4.

## Most influential descendants
- K201695: Patent Hemostasis Band (PH Band) (2020), 0 descendants of its own

## Indications for use
The compression device is used to assist patent hemostasis of the radial artery after a transradial procedure.

Source page: https://510kreport.com/device/K162027
Methodology: https://510kreport.com/methodology