# K132720: Heartspan Fixed Curve Braided Transseptal Sheath

- Pathway: 510(k) (Traditional)
- Applicant: Merit Medical Systems, Inc.
- Decided: Feb 12, 2014 after 166 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 K004026 (2001). 1 ancestor in all.
1 later device descends from it; 1 cites 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)
- K004026: Braided Guiding Introducer, Thomas Medical Products, Inc. (2001) Summary page 1.

## Most influential descendants
- K171988: Performer Guiding Sheath (2018), 0 descendants of its own

## Indications for use
For the percutaneous introduction of various types of cardiovascular catheters to all heart chambers, including the left atrium via transseptal puncture.

Source page: https://510kreport.com/device/K132720
Methodology: https://510kreport.com/methodology