# K063182: Enpath Medical Viaseal Valved Peelable Introducer, Model 10866-XXX

- Pathway: 510(k) (Traditional)
- Applicant: Enpath Medical, Inc.
- Decided: Dec 21, 2006 after 63 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: 4 generations back to K932323 (1993). 6 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040150: Modification to Medamicus Flowguard Peelable Introducer, Medamicus, Inc. (2004) Summary page 2.
- K003731: Safesheath MSP Introducer Sheath Kit with Integral Hemostasis Valve, Thomas Medical Products, Inc. (2001) Summary page 2.

## Most influential descendants
- K093232: Optiseal Enpath Valved Ptfe Peelable Introducer (2010), 0 descendants of its own
- K072248: Viapeel Peelable Introducer (2007), 0 descendants of its own

## Indications for use
The Enpath ViaSeal Valved Peelable Introducer is indicated for use in the percutaneous insertion of pacing leads or catheters in the venous system.

Source page: https://510kreport.com/device/K063182
Methodology: https://510kreport.com/methodology