# K212165: Reprocessed Carto Vizigo Bi-Directional Guiding Sheath

- Pathway: 510(k) (Traditional)
- Applicant: Innovative Health, LLC
- Decided: Mar 10, 2022 after 241 days
- Product code: PNE (Reprocessed Catheter Introducer)
- 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: 5 generations back to K964518 (1997). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170997: CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath, Biosense Webster, Inc. (2017) Summary page 5.

## Indications for use
The Reprocessed Carto Vizigo Bi-Directional Guiding Sheath is indicated for introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum. The sheath curve can be visualized when used with compatible Carto 3 EP Navigation Systems.

Source page: https://510kreport.com/device/K212165
Methodology: https://510kreport.com/methodology