# K093232: Optiseal Enpath Valved Ptfe Peelable Introducer

- Pathway: 510(k) (Traditional)
- Applicant: Great Batch Medical
- Decided: Mar 15, 2010 after 152 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). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 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 2.
- K070159: Prelude Sheath Introducer, Merit Medical Systems, Inc. (2007) Summary page 2.

## Recalls of this device
- Jul 2, 2010 · Not classified · Z-2294-2010: The outer sterile barrier (pouch) packaging for the 12 Fr device is not intact. No breaches in the inner sterile barrier (tray/tyvek lid) have been identified. The OptiSeal introducer and accessories 

## Indications for use
The OptiSealTM Valved 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/K093232
Methodology: https://510kreport.com/methodology