Cleared Traditional

Arrow? Endurance? Extended Dwell Peripheral Catheter System (EDC-00818)

K243599 · Arrow International, LLC (A subsidiary of Teleflex, Inc.) · General Hospital

Mar 2025

Decision

113d

Days

Class 2

Risk

About This 510(k) Submission

K243599 is an FDA 510(k) clearance for the Arrow? Endurance? Extended Dwell Peripheral Catheter System (EDC-00818), a Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (Class II — Special Controls, product code FOZ), submitted by Arrow International, LLC (A subsidiary of Teleflex, Inc.) (Morrisville, US). The FDA issued a Cleared decision on March 14, 2025, 113 days after receiving the submission on November 21, 2024. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5200.

Submission Details

510(k) Number	K243599 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 21, 2024
Decision Date	March 14, 2025
Days to Decision	113 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF

Device Classification

Product Code	FOZ — Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 880.5200