# K004026: Braided Guiding Introducer

- Pathway: 510(k) (Traditional)
- Applicant: Thomas Medical Products, Inc.
- Decided: Jul 9, 2001 after 194 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.
4 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K132720: Heartspan Fixed Curve Braided Transseptal Sheath (2014), 1 descendant of its own
- K013202: Modification to Braided Guiding Introducer (2001), 1 descendant of its own
- K171988: Performer Guiding Sheath (2018), 0 descendants of its own
- K040713: Modification to Braided Guiding Introducer System (2004), 0 descendants of its own

Source page: https://510kreport.com/device/K004026
Methodology: https://510kreport.com/methodology