# K990333: Medtronic PS Medical Introducer Sheath 12F,14F,15F, Models 3805-012, 3805-014, 3805-015

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic PS Medical
- Decided: Apr 28, 1999 after 84 days
- Product code: GWG (Endoscope, Neurological)
- Device class: 2
- Regulation: 21 CFR 882.1480
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K883607 (1988). 2 ancestors in all.
2 later devices descend from it; 2 cite 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)
- K931973: Disposable Peel-Away Introducer Sheath, Neuro Navigational Corp. (1993) Summary page 1.
- K883607: Peel-Away Introducer for Ventricular Catheter, Codman & Shurtleff, Inc. (1988) Summary page 1.

## Most influential descendants
- K200925: Clarus Peel-Away Introducer Sheath (2021), 0 descendants of its own
- K061135: Minop Disposable Introducer 10F, Model ME010; 19F, Model ME019 (2006), 0 descendants of its own

## Recalls of this device
- Jul 5, 2005 · Not classified · Z-1111-05: Cracked hubs/handles and/or improper peeling of the sheath during use.
- Jul 5, 2005 · Not classified · Z-1110-05: Cracked hubs/handles and/or improper peeling of the sheath during use.

## Indications for use
The Introducer Sheath is a device used to make a channel through the brain into the ventricular system.

Source page: https://510kreport.com/device/K990333
Methodology: https://510kreport.com/methodology