# K122926: Sureflex Steerable Guiding Sheath Kit

- Pathway: 510(k) (Traditional)
- Applicant: Baylis Medical Co., Inc.
- Decided: Jan 24, 2013 after 122 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
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K061633: Agilis NxT Steerable Introducer. Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K190688: VersaCross Steerable Sheath, VersaCross Transseptal Dilator (2019), 1 descendant of its own
- K232037: Reprocessed VersaCross Steerable Sheath; Reprocessed SureFlex Steerable Guiding Sheath (2024), 0 descendants of its own

## Indications for use
The SureFlexTM Steerable Guiding Sheath Kit 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/K122926
Methodology: https://510kreport.com/methodology