# K991259: TE ME NA Epidural Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Te ME NA S.A.R.L.
- Decided: Feb 21, 2001 after 680 days
- Product code: BSO (Catheter, Conduction, Anesthetic)
- Device class: 2
- Regulation: 21 CFR 868.5120
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K060186: Polyplex Stimulating Catheter System (2006), 0 descendants of its own

## Indications for use
The Te me na Polymedic Epidural Anesthesia Catheter is intended for administration of local anesthetics into the epidural space to provide continuous epidural or caudal anesthesia for up to 72 hours.

Source page: https://510kreport.com/device/K991259
Methodology: https://510kreport.com/methodology