# K151513: Arrow Endurance Extended Dwell Peripheral Catheter System

- Pathway: 510(k) (Traditional)
- Applicant: Arrow Internation, Inc. (Subsidiary of Teleflex Inc.)
- Decided: Jul 8, 2015 after 34 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: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K810675 (1981). 4 ancestors in all.
4 later devices descend from it; 2 cite it directly.
4 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032843: Nexiva Closed IV Catheter System, Becton Dickinson Infusion Therapy Systems, Inc. (2004) Summary page 4.
- K021120: Radial Artery Catherization Set with Integral Needle Protection,Model RA-04020-SP, Arrow Intl., Inc. (2002) Summary page 4.

## Most influential descendants
- K152272: Arrow Endurance Extended Dwell Peripheral Catheter System (2015), 3 descendants of its own
- K163513: Arrow Endurance Extended Dwell Peripheral Catheter System (2017), 2 descendants of its own
- K243599: Arrow™ Endurance™ Extended Dwell Peripheral Catheter System (EDC-00818) (2025), 0 descendants of its own
- K242281: Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00620); Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00622); Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00820); Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00822) (2024), 0 descendants of its own

## Recalls of this device
- Dec 15, 2017 · Class II · Z-1194-2018: Certain lots of peripheral catheter systems may be missing the safety latch, intended to minimize the risk of sharps injuries.

## Indications for use
The ARROW Endurance catheter system permits access to the patient’s peripheral vascular system for short-term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids. The catheter may be used for high pressure injection. The safety feature is intended to minimize the risk of sharps injuries.

Source page: https://510kreport.com/device/K151513
Methodology: https://510kreport.com/methodology