# K883607: Peel-Away Introducer for Ventricular Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Codman & Shurtleff, Inc.
- Decided: Sep 30, 1988 after 38 days
- Product code: GYK (Instrument, Shunt System Implantation)
- Device class: 1
- Regulation: 21 CFR 882.4545
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K990333: Medtronic PS Medical Introducer Sheath 12F,14F,15F, Models 3805-012, 3805-014, 3805-015 (1999), 2 descendants of its own
- 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

Source page: https://510kreport.com/device/K883607
Methodology: https://510kreport.com/methodology