FDA Product Code
FDA Product Code FOZ — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General Hospital
- 21 CFR Citation
- 880.5200
510(k) Clearances — 508 records · page 1 of 6
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K260432 | Ruby Intravascular Catheter | Venocare, Inc. | 2026-09-02 | Traditional | PDF ↗ |
| K260165 | Unimpregnated Central Venous Catheter | Spectrum Vascular | 2026-08-10 | Traditional | PDF ↗ |
| K261041 | ClearSafe Closed System | MedSource Labs, LLC | 2026-07-10 | Traditional | PDF ↗ |
| K260539 | MedSource QuickSafe Safety IV Catheter; MedSource PurSafe Safety IV Catheter | MedSource Labs, LLC | 2026-07-09 | Traditional | PDF ↗ |
| K253235 | Introcan Safety® Deep Access XL IV Catheter | B.Braun Medical, Inc. | 2026-05-15 | Traditional | PDF ↗ |
| K252137 | BD Insyte IV Catheter | Becton Dickinson Infusion Therapy Systems, Inc. | 2026-04-02 | Traditional | PDF ↗ |
| K252513 | Polywin 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 14mm, 26G x 14mm); Polywin Safety Adva (20G x 45mm; 22G x 64mm; 22G x 45mm ; 24G x 32 mm; 24G x 14mm; 14G x 51mm; 16G x 51mm; 18G x 64mm; 20G x 64mm, 26G x 14mm) | Poly Medicure Limited | 2026-04-01 | Special | PDF ↗ |
| K252398 | SURFLO Hybria Closed System Safety IV Catheter | Terumo Medical Products (Hangzhou) Co., Ltd. | 2025-12-17 | Traditional | PDF ↗ |
| K252677 | Polyshield Safety IV Catheters | Poly Medicure Limited | 2025-11-05 | Special | PDF ↗ |
| K251422 | BD Saf-T-Intima Subcutaneous Catheter System | Becton Dickinson Infusion Therapy Systems, Inc. | 2025-10-08 | Traditional | PDF ↗ |
| K243403 | BD Nexiva Closed IV Catheter System | Becton Dickinson Infusion Therapy Systems, Inc. | 2025-07-25 | Traditional | PDF ↗ |
| K251155 | BD Cathena Safety IV Catheter | Becton Dickinson Infusion Therapy Systems, Inc. | 2025-07-11 | Traditional | PDF ↗ |
| K251654 | BD Insyte Autoguard Shielded IV Catheter, BD Insyte Autoguard BC Shielded IV Catheter and BD Insyte Autoguard BC Pro Shielded IV Catheter | Becton Dickinson Infusion Therapy Systems, Inc. | 2025-06-27 | Special | PDF ↗ |
| K250682 | BD Nexiva Diffusics Closed IV Catheter System and BD Nexiva Diffusics Closed IV Catheter System with BD MaxZero Needle-free Connector | Becton Dickinson Infusion Therapy Systems, Inc. | 2025-06-03 | Traditional | PDF ↗ |
| K243105 | Ruby Intravascular Catheter | Venocare, Inc. | 2025-05-16 | Traditional | PDF ↗ |
| K250292 | OSPREY Midline Closed IV Catheter System (OspreyEDC-F20) | Skydance Vascular, Inc. | 2025-05-02 | Traditional | PDF ↗ |
| K244059 | HydroMID 5F Dual Lumen Midline Catheter - Basic Kit (70006102); HydroMID 5F Dual Lumen Midline Catheter - Max Barrier Kit (70006104); HydroMID 5F Dual Lumen Midline Catheter - Mobile Max Barrier Kit (90006104) | Access Vascular, Inc. | 2025-03-27 | Special | PDF ↗ |
| K243599 | Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00818) | Arrow International, LLC (A subsidiary of Teleflex, Inc.) | 2025-03-14 | Traditional | PDF ↗ |
| 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) | Arrow International, LLC (A subsidiary of Teleflex, Inc.) | 2024-12-20 | Traditional | PDF ↗ |
| K241115 | SV Spectrum MRC Central Venous Catheter; SV Spectrum MR Central Venous Catheter; SV Central Venous Catheter | Spectrum Vascular | 2024-11-27 | Traditional | PDF ↗ |
| K240359 | PowerGlide Pro Midline Catheter | Becton, Dickinson and Company (Bard Access Systems, Inc.) | 2024-07-29 | Traditional | PDF ↗ |
| K241845 | Introcan Safety® 2 IV Catheter | B.Braun Medical, Inc. | 2024-07-26 | Special | PDF ↗ |
| K233106 | AccuCath Ace Intravascular Catheter | Bard Access Systems, Inc. (C.R. Bard, Inc.) | 2024-04-19 | Traditional | PDF ↗ |
| K232234 | Nouvo Safety Set | Poly Medicure Limited | 2024-03-15 | Traditional | PDF ↗ |
| K233529 | BD Nexiva Diffusics Closed IV Catheter System with BD MaxZero Needle-free Connector | Becton Dickinson Infusion Therapy Systems, Inc. | 2023-12-01 | Special | PDF ↗ |
| K231239 | Nexiva Closed IV Catheter System with NearPort IV Access | Becton Dickinson Infusion Therapy Systems, Inc. | 2023-09-22 | Traditional | PDF ↗ |
| K231401 | Polysafety BC, Polysafety BC Adva, Polywin Safety, Polywin Safety Adva | Poly Medicure Limited | 2023-09-21 | Traditional | PDF ↗ |
| K223788 | The MedSource TrueSafe Blood Control I.V. Safety Catheter, and the MedSource ClearSafe Blood Control I.V. Safety Catheter | Medsource International, LLC | 2023-09-15 | Traditional | PDF ↗ |
| K231626 | OSPREY Closed IV Catheter System (OspreyV2) | Skydance Vascular, Inc. | 2023-08-31 | Traditional | PDF ↗ |
| K221827 | Mais Central Venous Catheter | Saudi Mais Co. For Medical Products | 2023-06-23 | Traditional | PDF ↗ |
| K230616 | Polyguard and Polyshield Safety IV Catheters | Poly Medicure Limited | 2023-05-05 | Traditional | PDF ↗ |
| K223018 | OSPREY PERIPHERAL IV Catheter System | Skydance Vascular, Inc. | 2023-04-14 | Traditional | PDF ↗ |
| K223648 | Cook® Spectrum® 2 MRC Central Venous Catheter | Cook Advanced Technologies | 2023-02-03 | Traditional | PDF ↗ |
| K220772 | HydroMID 4F Single Lumen Midline Catheter | Access Vascular, Inc. | 2022-12-07 | Traditional | PDF ↗ |
| K210929 | MagiCath II | Woo Young Medical Co., Ltd. | 2022-09-13 | Traditional | PDF ↗ |
| K212370 | Leaderflex Mini and Leaderflex Nano | Vygon USA | 2022-08-29 | Traditional | PDF ↗ |
| K220756 | Introcan Safety 2 IV Catheter | B.Braun Medical, Inc. | 2022-06-23 | Special | PDF ↗ |
| K220626 | Introcan Safety IV Catheter | B.Braun Medical, Inc. | 2022-05-14 | Special | PDF ↗ |
| K220584 | BD Cathena Safety IV Catheter | Becton Dickinson Infusion Therapy Systems, Inc. | 2022-03-31 | Special | PDF ↗ |
| K210037 | Pluski Safe 1 Safety IV Catheter | Mediplus (India) Limited | 2022-03-25 | Traditional | PDF ↗ |
| K213664 | B. Braun Introcan Safety 2 IV Catheter | B.Braun Medical, Inc. | 2022-02-11 | Special | PDF ↗ |
| K213085 | Introcan Safety 3 Closed IV Catheter | B.Braun Medical, Inc. | 2021-10-25 | Special | PDF ↗ |
| K202060 | Disposable IV catheter | Shinva Ande Healthcare Apparatus Co., Ltd. | 2021-07-23 | Traditional | PDF ↗ |
| K200891 | BD Intima II Closed IV Catheter System, BD Intima II PLUS Closed IV Catheter System | Becton, Dickinson and Company | 2021-06-02 | Traditional | PDF ↗ |
| K203069 | HydroMID | Access Vascular, Inc. | 2021-02-08 | Abbreviated | PDF ↗ |
| K201075 | BD Insyte Autoguard Shielded IV Catheter, BD Insyte Autoguard BC Shielded IV Catheter, BD Insyte Autoguard BC Pro Shielded IV Catheter | Becton, Dickinson and Company | 2020-12-18 | Traditional | PDF ↗ |
| K193158 | ACENT Central Venous Catheter | Global Medikit Limited | 2020-11-24 | Traditional | PDF ↗ |
| K201717 | BD Cathena Safety IV Catheter | Becton Dickinson Infusion Therapy Systems, Inc. | 2020-09-22 | Special | PDF ↗ |
| K200373 | Deltaven Fast Flash Closed I.V. Catheter Systems | Delta Med Spa | 2020-08-26 | Traditional | PDF ↗ |
| K193278 | MedSource CathMED IV Catheter | Medsource Labs | 2020-08-07 | Traditional | PDF ↗ |
| K192230 | MF SAFECATH | Medifirst Co., Ltd. | 2020-04-23 | Traditional | PDF ↗ |
| K200266 | BD Centro Vena Acute Central Line (7 French Dual Lumen) | Bard Access Systems, Inc. (Bard Has Joined Bd) | 2020-04-07 | Special | PDF ↗ |
| K192676 | Introcan Safety 2 IV Catheter 18-24 gauge | B.Braun Medical, Inc. | 2020-04-01 | Traditional | PDF ↗ |
| K200263 | Health Line CT Midline Catheter | Health Line International Corporation | 2020-03-12 | Special | PDF ↗ |
| K192493 | BD Cathena (TM) Safety IV Catheter | Becton Dickinson Infusion Therapy Systems, Inc. | 2020-01-24 | Traditional | PDF ↗ |
| K192533 | Health Line CT CVC | Health Line International Corporation | 2019-12-10 | Traditional | PDF ↗ |
| K190855 | BD Acute Central Line | Bard Access Systems, Inc. (Bard Has Joined Bd) | 2019-11-01 | Traditional | PDF ↗ |
| K190001 | Supercath 5 | Togo Medikit Co., Ltd. | 2019-09-20 | Traditional | PDF ↗ |
| K191232 | AccuCath Ace Intravascular Catheter | C.R. Bard, Inc. | 2019-09-18 | Traditional | PDF ↗ |
| K182252 | Cook Unimpregnated Central Venous Catheter | Cook Incorporated | 2019-05-17 | Traditional | PDF ↗ |
| K183399 | BD Nexiva Closed IV Catheter System | Becton Dickinson Infusion Therapy Systems, Inc. | 2019-03-20 | Traditional | PDF ↗ |
| K182870 | Introcan Safety 3 Closed IV Catheter | B.Braun Medical, Inc. | 2019-03-07 | Traditional | PDF ↗ |
| K182538 | Merit RadialFlo Arterial Catheter | Merit Medical Singapore Pte. , Ltd. | 2019-01-16 | Abbreviated | PDF ↗ |
| K172496 | SUPERCATH 5 (26G) | Togo Medikit Co., Ltd. | 2018-03-23 | Traditional | PDF ↗ |
| K171530 | Deltaven XiV Max, Deltaven XiV Max FF | Delta Med Spa | 2017-12-21 | Traditional | PDF ↗ |
| K173354 | BD Nexiva Diffusics Closed IV Catheter Systems | Becton Dickinson Infusion Therapy Systems, Inc. | 2017-12-15 | Traditional | PDF ↗ |
| K172506 | BD Cathena Safety IV Catheter | Becton, Dickinson and Company | 2017-09-17 | Traditional | PDF ↗ |
| K172204 | BD Intima II PLUS Closed IV Catheter System | Becton, Dickinson and Company | 2017-08-17 | Traditional | PDF ↗ |
| K163358 | Introcan Safety 3 Closed IV Catheter | B.Braun Melsungen AG | 2017-04-28 | Special | PDF ↗ |
| K170336 | BD Nexiva Closed IV Catheter System (Single Port) with MaxZero Needleless Connector | Becton, Dickinson and Company | 2017-03-10 | Traditional | PDF ↗ |
| K161681 | Nipro SafeTouch IV Catheter | Nipro Medical Corporation | 2017-03-08 | Traditional | PDF ↗ |
| K170283 | BD Nexiva Diffusics Closed IV Catheter System | Becton, Dickinson and Company | 2017-02-28 | Traditional | PDF ↗ |
| K163513 | Arrow Endurance Extended Dwell Peripheral Catheter System | Arrow International, Inc. (Subsidiary of Teleflex, Inc.) | 2017-02-24 | Special | PDF ↗ |
| K162894 | AccuCath Intravascular Catheter | C.R. Bard, Inc. | 2016-11-15 | Special | PDF ↗ |
| K161779 | MedSource TrueSafe Safety IV Catheter, MedSource TrueSafe Comfort Safety IV Catheter | Medsource International, LLC | 2016-11-03 | Traditional | PDF ↗ |
| K162377 | PowerGlide Pro Midline Catheter | C.R. Bard, Inc. | 2016-09-22 | Special | PDF ↗ |
| K161866 | BioFlo Midline Catheter | Navilyst Medical, Inc. | 2016-09-08 | Traditional | PDF ↗ |
| K161777 | BD Nexiva and BD Nexiva Diffusics Closed IV Catheter Systems | Becton Dickinson Infusion Therapy Systems, Inc. | 2016-08-29 | Traditional | PDF ↗ |
| K160592 | SUPERCATH 6 | Togo Medikit Co., Ltd. | 2016-08-12 | Traditional | PDF ↗ |
| K160235 | ViaValve Safety I.V. Catheter | Smiths Medical Asd, Inc. | 2016-06-30 | Traditional | PDF ↗ |
| K153280 | PowerGlide Pro Midline Catheter | C.R. Bard, Inc. | 2016-06-02 | Traditional | PDF ↗ |
| K160374 | 20G x 1.25 NovaCath Secure IV Catheter System, 24G x 0.56 NovaCath Secure IV Catheter System | Tangent Medical Technologies, Inc. | 2016-03-11 | Special | PDF ↗ |
| K153298 | AccuCath Intravascular Catheter | C.R. Bard, Inc. | 2015-12-10 | Special | PDF ↗ |
| K152272 | Arrow Endurance Extended Dwell Peripheral Catheter System | Arrow International, Inc. (Subsidiary of Teleflex, Inc.) | 2015-11-23 | Traditional | PDF ↗ |
| K151698 | BD Angiocath IV Catheter, BD Insyte IV Catheter | Becton Dickinson Infusion Therapy Systems, Inc. | 2015-07-27 | Traditional | PDF ↗ |
| K150611 | MedSource ClearSafe Safety IV Catheter | Medsource International | 2015-07-15 | Traditional | PDF ↗ |
| K151513 | Arrow Endurance Extended Dwell Peripheral Catheter System | Arrow Internation, Inc. (Subsidiary of Teleflex Inc.) | 2015-07-08 | Traditional | PDF ↗ |
| K142797 | I.V. Catheter | Jiangxi Sanxin Medtec Co., Ltd. | 2015-06-18 | Traditional | PDF ↗ |
| K150109 | Arrow Pressure Injectable Jugular Axillo-subclavian Central Catheter (JACC) with Sustain Technology | Arrow International (A Subsidiary of Teleflex, Inc.) | 2015-06-05 | Traditional | PDF ↗ |
| K150407 | BioFlo Midline Catheter | Navilyst Medical, Inc. | 2015-05-15 | Abbreviated | PDF ↗ |
| K143610 | BD INTIMA II CLOSED IV CATHETER | Becton Dickinson Infusion Therapy Systems, Inc. | 2015-04-09 | Traditional | PDF ↗ |
| K142136 | ACCUCATH MIDLINE CATHETER SYSTEM | Vascular Pathways, Inc. | 2015-01-08 | Traditional | PDF ↗ |
| K140270 | NEXUS MIDLINE CT CATHETER | Health Line International Corporation | 2014-08-20 | Traditional | PDF ↗ |
| K141026 | LEADERFLEX | Vygon | 2014-07-30 | Traditional | PDF ↗ |
| K140504 | ACCUCATH BC INTRAVASCULAR CATHETER SYSTEM | Vascular Pathways, Inc. | 2014-07-17 | Traditional | PDF ↗ |
| K133280 | TERUMO SURFLO I.V. CATHETER | Terumo (Philippines) Corporation | 2014-06-12 | Traditional | PDF ↗ |
| K141138 | SURFLASH SAFETY I.V. CATHETER | Kofu Factory of Terumo Corp. | 2014-05-30 | Special | PDF ↗ |
| K140419 | SUPERCATH5 | Togo Medikit Co., Ltd. | 2014-05-12 | Traditional | PDF ↗ |
| K140136 | NIPRO SAFETOUCH PSV SCALP VEIN SET WITH SAFETY DEVICE | Nipro Medical Corporation | 2014-02-14 | Special | PDF ↗ |
| K131555 | MEDSOURCE IV SAFETY CATHETER | Medsource International, LLC | 2014-01-31 | Traditional | PDF ↗ |
Product code FOZ · Class II · General Hospital. Data: openFDA.