# K243599: Arrow™ Endurance™ Extended Dwell Peripheral Catheter System (EDC-00818)

- Pathway: 510(k) (Traditional)
- Applicant: Arrow International, LLC (A subsidiary of Teleflex, Inc.)
- Decided: Mar 14, 2025 after 113 days
- Product code: FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days)
- Device class: 2
- Regulation: 21 CFR 880.5200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K810675 (1981). 7 ancestors in all.
No later device cites it as a predicate yet.
4 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163513: Arrow Endurance Extended Dwell Peripheral Catheter System, Arrow International, Inc. (Subsidiary of Teleflex, Inc.) (2017) Summary page 5.

## Indications for use
The Arrow™ Endurance™ Extended Dwell Peripheral Catheter System permits access to the patient’s peripheral vascular system for short-term venous use (less than 30 days) to sample blood, administer fluids, and perform high pressure contrast injections at a maximum of 325 psi. The Arrow™ Endurance™ Extended Dwell Peripheral Catheter System permits access to the patient’s peripheral vascular system for short-term use (less than 30 days) to facilitate arterial blood pressure measurement and blood sampling. The safety feature is intended to minimize the risk of sharps injuries. The Arrow™ Endurance™ Extended Dwell Peripheral Catheter may be used for any patient population with consideration given to adequacy of anatomy and appropriateness of the procedure. The Arrow™ Endurance™ Extended Dwell Peripheral Catheter may be used in hospitals, clinics, and other advanced clinical facilities.

Source page: https://510kreport.com/device/K243599
Methodology: https://510kreport.com/methodology