# K034025: NMT Medical Transseptal Sheath Set, Models TSS-10-HSC, TSS-11-HSC, TSS12-HSC

- Pathway: 510(k) (Traditional)
- Applicant: Nmt Medical, Inc.
- Decided: Mar 26, 2004 after 88 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.
9 later devices descend from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) COOK Check-Flo® Transseptal Introducer Sets: named in the summary without a submission number

## Most influential descendants
- K083793: Steerable Guide Catheter (2009), 8 descendants of its own
- K091596: Evalve Steerable Guide Catheter, Model SGC01ST (2009), 7 descendants of its own
- K093866: Evalve Steerable Guide Catheter (2010), 6 descendants of its own
- K100789: Modificaton to: Steerable Guide Catheter, Model SGC01ST (2010), 5 descendants of its own
- K120086: Cariosolutions Percu-Pro Steerable Introdcer 65CM Cariosolutions Percu-Pro Steerable Introducer 80CM (2012), 2 descendants of its own

## Indications for use
The NMT Medical Transseptal Sheath Set is indicated for percutaneous introduction of various cardiovascular devices into the left side of the heart through the atrial septum.

Source page: https://510kreport.com/device/K034025
Methodology: https://510kreport.com/methodology