# K153246: PTFE Super Sheath Introducer 2.1

- Pathway: 510(k) (Special)
- Applicant: Medcomp (Medical Components, Inc.)
- Decided: Feb 12, 2016 after 95 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: 7 generations back to K932323 (1993). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130855: Ptfe Super Sheath Introducer, Martech Medical Products (2013) Summary page 4.

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

Source page: https://510kreport.com/device/K153246
Methodology: https://510kreport.com/methodology