# K232037: Reprocessed VersaCross Steerable Sheath; Reprocessed SureFlex Steerable Guiding Sheath

- Pathway: 510(k) (Traditional)
- Applicant: Innovative Health, LLC
- Decided: Apr 4, 2024 after 269 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: 2 generations back to K122926 (2013). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190688: VersaCross Steerable Sheath, VersaCross Transseptal Dilator, Baylis Medical Company, Inc. (2019) Summary page 6.
- K122926: Sureflex Steerable Guiding Sheath Kit, Baylis Medical Co., Inc. (2013) Summary page 6.

## Indications for use
The Reprocessed VersaCross Steerable Sheath is indicated for introducing various cardiovascular catheters to the heart, including the left side of the heart through the interatrial septum. The Reprocessed SureFlex Steerable Guiding Sheath is indicated for introducing various cardiovascular catheters to the heart, including the left side of the heart through the interatrial septum.

Source page: https://510kreport.com/device/K232037
Methodology: https://510kreport.com/methodology