# K212626: PathBuilder Transseptal Guiding Introducer

- Pathway: 510(k) (Traditional)
- Applicant: Shanghai Microport EP Medtech Co., Ltd.
- Decided: Mar 23, 2022 after 217 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: 1 generation back to K964518 (1997). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K964518: Fast-Cath Transseptal Catheter Introducer, Daig Corp. (1997) Summary page 5.

## Indications for use
The PathBuilder Transseptal Guiding Introducer is indicated for introducing various cardiovascular catheters into the left side of the heart through the interatrial septum.

Source page: https://510kreport.com/device/K212626
Methodology: https://510kreport.com/methodology