# K212708: Halo One Thin-Walled Guiding Sheath

- Pathway: 510(k) (Special)
- Applicant: C.R. Bard, Inc.
- Decided: Sep 23, 2021 after 28 days
- Product code: DYB (Introducer, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1340
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K984500 (1998). 3 ancestors in all.
No later device cites it as a predicate yet.
1 of 4 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192313: Halo One Thin-Walled Guiding Sheath, C.R. Bard, Inc. (2019) Summary page 4.

## 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/K212708
Methodology: https://510kreport.com/methodology