# K120617: Ptfe Super Sheath Introducer

- Pathway: 510(k) (Traditional)
- Applicant: Martech Medical Products
- Decided: Nov 19, 2012 after 264 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: 5 generations back to K932323 (1993). 10 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000313: Tearaway Introducer Sheath, Xentek Medical, Inc. (2000) Summary page 1.
- K053092: Medcomp Vascu-Sheath II, Medcomp (2006) Summary page 1.
- K090394: Valved Tearway Introducer, Medcomp (2009) Summary page 1.

## Most influential descendants
- K130855: Ptfe Super Sheath Introducer (2013), 1 descendant of its own
- K153246: PTFE Super Sheath Introducer 2.1 (2016), 0 descendants of its own

## Indications for use
The PTFE Super Sheath Introducers are intended to obtain central venous access to tfacilitate catheter insertion or placing pacing leads into the central venous; system.

Source page: https://510kreport.com/device/K120617
Methodology: https://510kreport.com/methodology