# K163513: Arrow Endurance Extended Dwell Peripheral Catheter System

- Pathway: 510(k) (Special)
- Applicant: Arrow International, Inc. (Subsidiary of Teleflex, Inc.)
- Decided: Feb 24, 2017 after 71 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: 2 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K810675 (1981). 6 ancestors in all.
2 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)
- K152272: Arrow Endurance Extended Dwell Peripheral Catheter System, Arrow International, Inc. (Subsidiary of Teleflex, Inc.) (2015) Summary page 4.
- K151513: Arrow Endurance Extended Dwell Peripheral Catheter System, Arrow Internation, Inc. (Subsidiary of Teleflex Inc.) (2015) Summary page 4.

## Most influential descendants
- 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
- May 19, 2023 · Class I · Z-1826-2023: Potential for catheter separation or leakage
- Dec 6, 2019 · Class II · Z-0837-2020: Potential sterility issue for specific lots of the Arrow Endurance" Extended Dwell Peripheral Catheter System, Product Code ASK-00820-FLH.

## Indications for use
The ARROW Endurance catheter system permits access to the patient’s peripheral vascular system for short-term use 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/K163513
Methodology: https://510kreport.com/methodology