Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00818)— 510(k) K243599

Name: FDA 510(k) clearance K243599
Creator: U.S. Food and Drug Administration
Published: 2025-03-14

Substantially Equivalent

Arrow International, LLC (A subsidiary of Teleflex, Inc.)

FDA 510(k) clearance K243599 for Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00818), Substantially Equivalent on 2025-03-14. Applicant: Arrow International, LLC (A subsidiary of Teleflex, Inc.). Device class: 2.

Clearance details

Applicant: Arrow International, LLC (A subsidiary of Teleflex, Inc.)
Product code: Code FOZ
Device class: Class 2
Regulation: 21 CFR 880.5200
Advisory panel: General Hospital
Date received: 2024-11-21
Decision date: 2025-03-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Morrisville, NC, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FOZ

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K260165 — Unimpregnated Central Venous Catheter2026-08-10
K261041 — ClearSafe Closed System2026-07-10
K260539 — MedSource QuickSafe Safety IV Catheter; MedSource PurSafe Safety IV Catheter2026-07-09
K253235 — Introcan Safety® Deep Access XL IV Catheter2026-05-15
K252137 — BD Insyte IV Catheter2026-04-02

More clearances from Arrow International, LLC (A subsidiary of Teleflex, Inc.)

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K242281 — Arrow Endurance Extended Dwell Peripheral Catheter System (4 models)2024-12-20
K220280 — Arrow Stiffening Stylet2022-08-30
K220363 — VPS Rhythm DLX Device with TipTracker Technology2022-08-22

Adverse events under product code FOZ

product code FOZ

Death: 38
Injury: 2,290
Malfunction: 25,858
Other: 11
Total: 28,197

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.