# K072248: Viapeel Peelable Introducer

- Pathway: 510(k) (Special)
- Applicant: Enpath Medical, Inc.
- Decided: Nov 9, 2007 after 88 days
- Product code: DYB (Introducer, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1340
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K932323 (1993). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063182: Enpath Medical Viaseal Valved Peelable Introducer, Model 10866-XXX, Enpath Medical, Inc. (2006) Summary page 1.

## Recalls of this device
- Nov 11, 2016 · Class II · Z-2781-2017: Greatbatch received complaints with the ViaPeel Introducer Sheath 5FR, of handles detaching during use.

## Indications for use
The ViaPeelTM 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/K072248
Methodology: https://510kreport.com/methodology