FOZ · Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
General Hospital · 21 CFR 880.5200 · Class 2
Overview
| Product Code | FOZ |
|---|---|
| Device Name | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days |
| Regulation | 21 CFR 880.5200 |
| Device Class | Class 2 |
| Review Panel | General Hospital |
| 3rd-Party Reviewable | Yes |
Identification
An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 503)
Showing 20 most recent of 503 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K252137 | BD Insyte IV Catheter | Becton Dickinson Infusion Therapy Systems, Inc. | Apr 2, 2026 | SESE |
| 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 | Apr 1, 2026 | SESE |
| K252398 | SURFLO Hybria Closed System Safety IV Catheter | Terumo Medical Products (Hangzhou) Co., Ltd. | Dec 17, 2025 | SESE |
| K252677 | Polyshield Safety IV Catheters | Poly Medicure Limited | Nov 5, 2025 | SESE |
| K251422 | BD Saf-T-Intima Subcutaneous Catheter System | Becton Dickinson Infusion Therapy Systems, Inc. | Oct 8, 2025 | SESE |
| K243403 | BD Nexiva Closed IV Catheter System | Becton Dickinson Infusion Therapy Systems, Inc. | Jul 25, 2025 | SESE |
| K251155 | BD Cathena Safety IV Catheter | Becton Dickinson Infusion Therapy Systems, Inc. | Jul 11, 2025 | SESE |
| 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. | Jun 27, 2025 | SESE |
| 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. | Jun 3, 2025 | SESE |
| K243105 | Ruby Intravascular Catheter | Venocare, Inc. | May 16, 2025 | SESE |
| K250292 | OSPREY Midline Closed IV Catheter System (OspreyEDC-F20) | Skydance Vascular, Inc. | May 2, 2025 | SESE |
| 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. | Mar 27, 2025 | SESE |
| K243599 | Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00818) | Arrow International, LLC (A subsidiary of Teleflex, Inc.) | Mar 14, 2025 | SESE |
| 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.) | Dec 20, 2024 | SESE |
| K241115 | SV Spectrum MRC Central Venous Catheter; SV Spectrum MR Central Venous Catheter; SV Central Venous Catheter | Spectrum Vascular | Nov 27, 2024 | SESE |
| K240359 | PowerGlide Pro Midline Catheter | Becton, Dickinson and Company (Bard Access Systems, Inc.) | Jul 29, 2024 | SESE |
| K241845 | Introcan Safety® 2 IV Catheter | B.Braun Medical, Inc. | Jul 26, 2024 | SESE |
| K233106 | AccuCath Ace Intravascular Catheter | Bard Access Systems, Inc. (C.R. Bard, Inc.) | Apr 19, 2024 | SESE |
| K232234 | Nouvo Safety Set | Poly Medicure Limited | Mar 15, 2024 | SESE |
| K233529 | BD Nexiva Diffusics Closed IV Catheter System with BD MaxZero Needle-free Connector | Becton Dickinson Infusion Therapy Systems, Inc. | Dec 1, 2023 | SESE |
Top Applicants
- Becton Dickinson Infusion Therapy Systems, Inc. — 30 clearances
- Menlo Care, Inc. — 22 clearances
- Parke-Davis Co. — 14 clearances
- B.Braun Medical, Inc. — 11 clearances
- Becton Dickinson Vascular Access, Inc. — 11 clearances
