ClearanceBrief
Panels › General Hospital › Product code FOZ · Class 2

Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days

Regulation 880.5200

9510(k)s in 12 months (508 all time)
6recalls in 12 months (394 all time)
359recalls that name a 510(k)
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Top companies in FOZ

Decided510(k)Device and applicantCode
Sep 2, 2026K260432Ruby Intravascular Catheter
Venocare, Inc.
FOZ
Aug 10, 2026K260165Unimpregnated Central Venous Catheter
Spectrum Vascular
FOZ
Jul 10, 2026K261041ClearSafe Closed System
MedSource Labs, LLC
FOZ
Jul 9, 2026K260539MedSource QuickSafe™ Safety IV Catheter; MedSource PurSafe™ Safety IV Catheter
MedSource Labs, LLC
FOZ
May 15, 2026K253235Introcan Safety® Deep Access XL IV Catheter
B.Braun Medical, Inc.
FOZ
Apr 2, 2026K252137BD Insyte™ IV Catheter
Becton Dickinson Infusion Therapy Systems, Inc.
FOZ
Apr 1, 2026K252513Polywin Safety (14G x 51mm; 16G x 51mm; 18G x 64mm; 20G x 64mm; 20G x 45mm; 22G x 64mm; 22G x 45mm; 24G x 32mm; 24G x 14
Poly Medicure Limited, IN
FOZ
Dec 17, 2025K252398SURFLO Hybria Closed System Safety IV Catheter
Terumo Medical Products (Hangzhou) Co., Ltd., CN
FOZ
Nov 5, 2025K252677Polyshield Safety IV Catheters
Poly Medicure Limited, IN
FOZ
Oct 8, 2025K251422BD Saf-T-Intima™ Subcutaneous Catheter System
Becton Dickinson Infusion Therapy Systems, Inc.
FOZ
Jul 25, 2025K243403BD Nexiva™ Closed IV Catheter System
Becton Dickinson Infusion Therapy Systems, Inc.
FOZ
Jul 11, 2025K251155BD Cathena™ Safety IV Catheter
Becton Dickinson Infusion Therapy Systems, Inc.
FOZ
Jun 27, 2025K251654BD Insyte™ Autoguard™ Shielded IV Catheter, BD Insyte™ Autoguard™ BC Shielded IV Catheter and BD Insyte™ Autoguard™ BC P
Becton Dickinson Infusion Therapy Systems, Inc.
FOZ
Jun 3, 2025K250682BD Nexiva™ Diffusics™ Closed IV Catheter System and BD Nexiva™ Diffusics™ Closed IV Catheter System with BD MaxZero™ Nee
Becton Dickinson Infusion Therapy Systems, Inc.
FOZ
May 16, 2025K243105Ruby Intravascular Catheter
Venocare, Inc.
FOZ
May 2, 2025K250292OSPREY Midline Closed IV Catheter System (OspreyEDC-F20)
Skydance Vascular, Inc.
FOZ
Mar 27, 2025K244059HydroMID 5F Dual Lumen Midline Catheter - Basic Kit (70006102); HydroMID 5F Dual Lumen Midline Catheter - Max Barrier Ki
Access Vascular, Inc.
FOZ
Mar 14, 2025K243599Arrow™ Endurance™ Extended Dwell Peripheral Catheter System (EDC-00818)
Arrow International, LLC (A subsidiary of Teleflex, Inc.)
FOZ
Dec 20, 2024K242281Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00620); Arrow Endurance Extended Dwell Peripheral Cathete
Arrow International, LLC (A subsidiary of Teleflex, Inc.)
FOZ
Nov 27, 2024K241115SV Spectrum MRC Central Venous Catheter; SV Spectrum MR Central Venous Catheter; SV Central Venous Catheter
Spectrum Vascular
FOZ
Jul 29, 2024K240359PowerGlide Pro™ Midline Catheter
Becton, Dickinson and Company (Bard Access Systems, Inc.)
FOZ
Jul 26, 2024K241845Introcan Safety® 2 IV Catheter
B.Braun Medical, Inc.
FOZ
Apr 19, 2024K233106AccuCath Ace™ Intravascular Catheter
Bard Access Systems, Inc. (C.R. Bard, Inc.)
FOZ
Mar 15, 2024K232234Nouvo Safety Set
Poly Medicure Limited, IN
FOZ
Dec 1, 2023K233529BD Nexiva™ Diffusics™ Closed IV Catheter System with BD MaxZero™ Needle-free Connector
Becton Dickinson Infusion Therapy Systems, Inc.
FOZ
Sep 22, 2023K231239Nexiva™ Closed IV Catheter System with NearPort™ IV Access
Becton Dickinson Infusion Therapy Systems, Inc.
FOZ
Sep 21, 2023K231401Polysafety BC, Polysafety BC Adva, Polywin Safety, Polywin Safety Adva
Poly Medicure Limited, IN
FOZ
Sep 15, 2023K223788The MedSource TrueSafe Blood Control I.V. Safety Catheter, and the MedSource ClearSafe Blood Control I.V. Safety Cathete
Medsource International, LLC
FOZ
Aug 31, 2023K231626OSPREY Closed IV Catheter System (OspreyV2)
Skydance Vascular, Inc.
FOZ
Jun 23, 2023K221827Mais Central Venous Catheter
Saudi Mais Co. For Medical Products, SA
FOZ
May 5, 2023K230616Polyguard and Polyshield Safety IV Catheters
Poly Medicure Limited, IN
FOZ
Apr 14, 2023K223018OSPREY PERIPHERAL IV Catheter System
Skydance Vascular, Inc.
FOZ
Feb 3, 2023K223648Cook® Spectrum® 2 MRC Central Venous Catheter
Cook Advanced Technologies
FOZ
Dec 7, 2022K220772HydroMID 4F Single Lumen Midline Catheter
Access Vascular, Inc.
FOZ
Sep 13, 2022K210929MagiCath II
Woo Young Medical Co., Ltd., KR
FOZ
Aug 29, 2022K212370Leaderflex Mini and Leaderflex Nano
Vygon USA
FOZ
Jun 23, 2022K220756Introcan Safety 2 IV Catheter
B.Braun Medical, Inc.
FOZ
May 14, 2022K220626Introcan Safety IV Catheter
B.Braun Medical, Inc.
FOZ
Mar 31, 2022K220584BD Cathena Safety IV Catheter
Becton Dickinson Infusion Therapy Systems, Inc.
FOZ
Mar 25, 2022K210037Pluski Safe 1 Safety IV Catheter
Mediplus (India) Limited, IN
FOZ
Feb 11, 2022K213664B. Braun Introcan Safety 2 IV Catheter
B.Braun Medical, Inc.
FOZ
Oct 25, 2021K213085Introcan Safety 3 Closed IV Catheter
B.Braun Medical, Inc.
FOZ
Jul 23, 2021K202060Disposable IV catheter
Shinva Ande Healthcare Apparatus Co., Ltd., CN
FOZ
Jun 2, 2021K200891BD Intima II Closed IV Catheter System, BD Intima II PLUS Closed IV Catheter System
Becton, Dickinson and Company
FOZ
Feb 8, 2021K203069HydroMID
Access Vascular, Inc.
FOZ
Dec 18, 2020K201075BD Insyte Autoguard Shielded IV Catheter, BD Insyte Autoguard BC Shielded IV Catheter, BD Insyte Autoguard BC Pro Shield
Becton, Dickinson and Company
FOZ
Nov 24, 2020K193158ACENT™ Central Venous Catheter
Global Medikit Limited, IN
FOZ
Sep 22, 2020K201717BD Cathena Safety IV Catheter
Becton Dickinson Infusion Therapy Systems, Inc.
FOZ
Aug 26, 2020K200373Deltaven Fast Flash Closed I.V. Catheter Systems
Delta Med Spa, IT
FOZ
Aug 7, 2020K193278MedSource CathMED IV Catheter
Medsource Labs
FOZ

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