# K161075: Arrow Epidural Catheter Kit

- Pathway: 510(k) (Traditional)
- Applicant: Teleflexmedical, Inc.
- Decided: Oct 4, 2016 after 169 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: 3 generations back to K884552 (1989). 4 ancestors in all.
No later device cites it as a predicate yet.
2 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143581: Arrow Epidural Catheter Kit, Teleflexmedical, Inc. (2015) Summary page 4.

## Indications for use
The Arrow Epidural Catheter kit permits access to the epidural space for the administration of epidural anesthetic. The epidural catheter kit is intended for use up to 72 hours. Patient Population: Adult

Source page: https://510kreport.com/device/K161075
Methodology: https://510kreport.com/methodology