# K151363: Zephyr Vascular Compression Device

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Vascular Dynamics
- Decided: Jul 31, 2015 after 71 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: 5 generations back to K984177 (1998). 9 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 11 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.
- K142122: Radar Vascular Compression Device, Advanced Vascular Dynamics (2014) Summary page 4.

## Cited in the summary but kept off the family tree
- K111831: MX-7000 Microxel, Bio-Med USA, Inc. (2011). Our reading of the summary gave K111831, FDA’s number for MX-7000 Microxel (Bio-Med USA, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Vasc Band”. Kept off the family tree. Summary page 4.

## Most influential descendants
- K170958: ChitoPulse 9in / 23 cm, ChitoPulse 12in / 30.5 cm, ChitoPulse 15in / 38 cm (2017), 0 descendants of its own

## Indications for use
The Zephyr™ Vascular Compression Devices are indicated for use by medical professionals to promote hemostasis following a catheterization or other puncture into a blood vessel in a patient’s arm or leg, including: radial, brachial, dorsalis pedis, or tibial blood vessels, arterial or venous line or sheath removal, hemodialysis, and in anticoagulation therapy.

Source page: https://510kreport.com/device/K151363
Methodology: https://510kreport.com/methodology