# K081394: Ptfe Interlock Peelable Introducers

- Pathway: 510(k) (Special)
- Applicant: Enpath Medical, Inc.
- Decided: Sep 15, 2008 after 119 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 K000824 (2000). 1 ancestor in all.
3 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000824: Percutaneous Introducer, Model 10383-XXX, Medamicus, Inc. (2000) Summary page 1.

## Most influential descendants
- K093023: Ptfe Peelable Introducer (2009), 2 descendants of its own
- K102540: Ptfe Portable Introducer (2010), 1 descendant of its own
- K123974: Percutaneous Introducer Kit (2013), 0 descendants of its own

## Indications for use
The PTFE Peelable Introducer is intended for use in the percutaneous insertion of pacing leads or catheters in the venous system.

Source page: https://510kreport.com/device/K081394
Methodology: https://510kreport.com/methodology