# K161183: Halo One Thin-Walled Guiding Sheath

- Pathway: 510(k) (Traditional)
- Applicant: C.R. Bard, Inc.
- Decided: Jun 3, 2016 after 37 days
- Product code: DYB (Introducer, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1340
- Recalls of this device: 3 (3 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K984500 (1998). 1 ancestor in all.
2 later devices descend from it; 1 cites it directly.
1 of 4 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K984500: Cordis Brite Tip Catheter Sheath Introducer System, Cordis Corp. (1998) Summary page 4.

## Most influential descendants
- K192313: Halo One Thin-Walled Guiding Sheath (2019), 1 descendant of its own
- K212708: Halo One Thin-Walled Guiding Sheath (2021), 0 descendants of its own

## Recalls of this device
- Dec 2, 2016 · Class I · Z-0968-2017: Complaints of sheath separation, kinking, and/or tip damage during use.
- Dec 2, 2016 · Class I · Z-0969-2017: Complaints of sheath separation, kinking, and/or tip damage during use.
- Dec 2, 2016 · Class I · Z-0970-2017: Complaints of sheath separation, kinking, and/or tip damage during use.

## Indications for use
The Halo One Thin-Walled Guiding Sheath is indicated for use in peripheral arterial and venous procedures requiring percutaneous introduction of intravascular devices. The Halo One Thin-Walled Guiding Sheath is NOT indicated for use in the neurovasculature nor the coronary vasculature.

Source page: https://510kreport.com/device/K161183
Methodology: https://510kreport.com/methodology