Product code FOZ— General Hospital
Arrow Endurance Extended Dwell Peripheral Catheter System
- Classification name
- Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
- Device class
- Class 2
- Regulation
- 21 CFR 880.5200
- Advisory panel
- General Hospital
- Total cleared
- 507
- First cleared
- Most recent
Market context for product code FOZ
FDA has cleared devices under product code FOZ between 1976 and 2026, filed by 225 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2026
- 2025
- 2024
- 2023
- 2022
- 2021
- 2020
- 2019
- 2018
- 2017
- 2016
- 2015
- 2014
- 2013
- 2012
Top applicants under product code FOZ
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, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code FOZ
1–100 of 507- K260165 — Unimpregnated Central Venous Catheter
- K261041 — ClearSafe Closed System
- K260539 — MedSource QuickSafe Safety IV Catheter; MedSource PurSafe Safety IV Catheter
- K253235 — Introcan Safety® Deep Access XL IV Catheter
- K252137 — BD Insyte IV Catheter
- K252513 — Polywin Safety (14G x 51mm +17 more
- K252398 — SURFLO Hybria Closed System Safety IV Catheter
- K252677 — Polyshield Safety IV Catheters
- K251422 — BD Saf-T-Intima Subcutaneous Catheter System
- K243403 — BD Nexiva Closed IV Catheter System
- K251155 — BD Cathena Safety IV Catheter
- K251654 — BD Insyte Autoguard Shielded IV Catheter, BD Insyte Autoguard BC Shielded IV Catheter and BD Insyte Autoguard BC Pro Shielded IV Catheter
- K250682 — BD Nexiva Diffusics Closed IV Catheter System and BD Nexiva Diffusics Closed IV Catheter System with BD MaxZero Needle-free Connector
- K243105 — Ruby Intravascular Catheter
- K250292 — OSPREY Midline Closed IV Catheter System (OspreyEDC-F20)
- K244059 — HydroMID 5F Dual Lumen Midline Catheter - Basic Kit (70006102) +2 more
- K243599 — Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00818)
- K242281 — Arrow Endurance Extended Dwell Peripheral Catheter System (4 models)
- K241115 — SV Spectrum MRC Central Venous Catheter; SV Spectrum MR Central Venous Catheter; SV Central Venous Catheter
- K240359 — PowerGlide Pro Midline Catheter
- K241845 — Introcan Safety® 2 IV Catheter
- K233106 — AccuCath Ace Intravascular Catheter
- K232234 — Nouvo Safety Set
- K233529 — BD Nexiva Diffusics Closed IV Catheter System with BD MaxZero Needle-free Connector
- K231239 — Nexiva Closed IV Catheter System with NearPort IV Access
- K231401 — Polysafety BC, Polysafety BC Adva, Polywin Safety, Polywin Safety Adva
- K223788 — The MedSource TrueSafe Blood Control I.V. Safety Catheter, and the MedSource ClearSafe Blood Control I.V. Safety Catheter
- K231626 — OSPREY Closed IV Catheter System (OspreyV2)
- K221827 — Mais Central Venous Catheter
- K230616 — Polyguard and Polyshield Safety IV Catheters
- K223018 — OSPREY PERIPHERAL IV Catheter System
- K223648 — Cook® Spectrum® 2 MRC Central Venous Catheter
- K220772 — HydroMID 4F Single Lumen Midline Catheter
- K210929 — MagiCath II
- K212370 — Leaderflex Mini and Leaderflex Nano
- K220756 — Introcan Safety 2 IV Catheter
- K220626 — Introcan Safety IV Catheter
- K220584 — BD Cathena Safety IV Catheter
- K210037 — Pluski Safe 1 Safety IV Catheter
- K213664 — B. Braun Introcan Safety 2 IV Catheter
- K213085 — Introcan Safety 3 Closed IV Catheter
- K202060 — Disposable IV catheter
- K200891 — BD Intima II Closed IV Catheter System, BD Intima II PLUS Closed IV Catheter System
- K203069 — HydroMID
- K201075 — BD Insyte Autoguard Shielded IV Catheter, BD Insyte Autoguard BC Shielded IV Catheter, BD Insyte Autoguard BC Pro Shielded IV Catheter
- K193158 — ACENT Central Venous Catheter
- K201717 — BD Cathena Safety IV Catheter
- K200373 — Deltaven Fast Flash Closed I.V. Catheter Systems
- K193278 — MedSource CathMED IV Catheter
- K192230 — MF SAFECATH
- K200266 — BD Centro Vena Acute Central Line (7 French Dual Lumen)
- K192676 — Introcan Safety 2 IV Catheter 18-24 gauge
- K200263 — Health Line CT Midline Catheter
- K192493 — BD Cathena (TM) Safety IV Catheter
- K192533 — Health Line CT CVC
- K190855 — BD Acute Central Line
- K190001 — Supercath 5
- K191232 — AccuCath Ace Intravascular Catheter
- K182252 — Cook Unimpregnated Central Venous Catheter
- K183399 — BD Nexiva Closed IV Catheter System
- K182870 — Introcan Safety 3 Closed IV Catheter
- K182538 — Merit RadialFlo Arterial Catheter
- K172496 — SUPERCATH 5 (26G)
- K171530 — Deltaven XiV Max, Deltaven XiV Max FF
- K173354 — BD Nexiva Diffusics Closed IV Catheter Systems
- K172506 — BD Cathena Safety IV Catheter
- K172204 — BD Intima II PLUS Closed IV Catheter System
- K163358 — Introcan Safety 3 Closed IV Catheter
- K170336 — BD Nexiva Closed IV Catheter System (Single Port) with MaxZero Needleless Connector
- K161681 — Nipro SafeTouch IV Catheter
- K170283 — BD Nexiva Diffusics Closed IV Catheter System
- K163513 — Arrow Endurance Extended Dwell Peripheral Catheter System
- K162894 — AccuCath Intravascular Catheter
- K161779 — MedSource TrueSafe Safety IV Catheter, MedSource TrueSafe Comfort Safety IV Catheter
- K162377 — PowerGlide Pro Midline Catheter
- K161866 — BioFlo Midline Catheter
- K161777 — BD Nexiva and BD Nexiva Diffusics Closed IV Catheter Systems
- K160592 — SUPERCATH 6
- K160235 — ViaValve Safety I.V. Catheter
- K153280 — PowerGlide Pro Midline Catheter
- K160374 — 20G x 1.25 NovaCath Secure IV Catheter System, 24G x 0.56 NovaCath Secure IV Catheter System
- K153298 — AccuCath Intravascular Catheter
- K152272 — Arrow Endurance Extended Dwell Peripheral Catheter System
- K151698 — BD Angiocath IV Catheter, BD Insyte IV Catheter
- K150611 — MedSource ClearSafe Safety IV Catheter
- K151513 — Arrow Endurance Extended Dwell Peripheral Catheter System
- K142797 — I.V. Catheter
- K150109 — Arrow Pressure Injectable Jugular Axillo-subclavian Central Catheter (JACC) with Sustain Technology
- K150407 — BioFlo Midline Catheter
- K143610 — BD INTIMA II CLOSED IV CATHETER
- K142136 — ACCUCATH MIDLINE CATHETER SYSTEM
- K140270 — NEXUS MIDLINE CT CATHETER
- K141026 — LEADERFLEX
- K140504 — ACCUCATH BC INTRAVASCULAR CATHETER SYSTEM
- K133280 — TERUMO SURFLO I.V. CATHETER
- K141138 — SURFLASH SAFETY I.V. CATHETER
- K140419 — SUPERCATH5
- K140136 — NIPRO SAFETOUCH PSV SCALP VEIN SET WITH SAFETY DEVICE
- K131555 — MEDSOURCE IV SAFETY CATHETER
- K133856 — POWERGLIDE MIDLINE CATHETER
Data sourced from openFDA. This site is unofficial and independent of the FDA.