# K060186: Polyplex Stimulating Catheter System

- Pathway: 510(k) (Traditional)
- Applicant: Te ME NA Sas
- Decided: Jul 18, 2006 after 175 days
- Product code: CAZ (Anesthesia Conduction Kit)
- Device class: 2
- Regulation: 21 CFR 868.5140
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K801912 (1980). 5 ancestors in all.
No later device cites it as a predicate yet.
1 of 6 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991259: TE ME NA Epidural Catheter, Te ME NA S.A.R.L. (2001) Summary page 1.
- K021567: Stimucath Continuous Nerve Block Set, Product Number AB-05000, Arrow Intl., Inc. (2002) Summary page 1.

## Indications for use
The Te me na POLYPLEX Stimulating Catheter System is intended for placement of catheters next to nerves and nerve plexuses for continuous nerve block anesthesia or analgesia techniques for periods not exceeding 72 hours.

Source page: https://510kreport.com/device/K060186
Methodology: https://510kreport.com/methodology