FOZ
- Product code
- FOZ
- Device name
- Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
- Device class
- Class 2
- 21 CFR
- 21 CFR 880.5200
- Medical specialty
- General Hospital
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 27
- Summaries archived here
- 25 (direct download)
- 510(k) clearances (all years, FDA)
- 507 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (27)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K260165 | 2026-08-10 | Spectrum Vascular | Unimpregnated Central Venous Catheter | |
| K261041 | 2026-07-10 | MedSource Labs, LLC | ClearSafe Closed System | |
| K260539 | 2026-07-09 | MedSource Labs, LLC | MedSource QuickSafe Safety IV Catheter; MedSource P… | FDA |
| K253235 | 2026-05-15 | B.Braun Medical, Inc. | Introcan Safety® Deep Access XL IV Catheter | |
| K252137 | 2026-04-02 | Becton Dickinson Infusion Therapy Syst… | BD Insyte IV Catheter | |
| K252513 | 2026-04-01 | Poly Medicure Limited | Polywin Safety (14G x 51mm; 16G x 51mm; 18G x 64mm; … | |
| K252398 | 2025-12-17 | Terumo Medical Products (Hangzhou) Co.… | SURFLO Hybria Closed System Safety IV Catheter | |
| K252677 | 2025-11-05 | Poly Medicure Limited | Polyshield Safety IV Catheters | |
| K251422 | 2025-10-08 | Becton Dickinson Infusion Therapy Syst… | BD Saf-T-Intima Subcutaneous Catheter System | |
| K243403 | 2025-07-25 | Becton Dickinson Infusion Therapy Syst… | BD Nexiva Closed IV Catheter System | |
| K251155 | 2025-07-11 | Becton Dickinson Infusion Therapy Syst… | BD Cathena Safety IV Catheter | |
| K251654 | 2025-06-27 | Becton Dickinson Infusion Therapy Syst… | BD Insyte Autoguard Shielded IV Catheter, BD Insyt… | |
| K250682 | 2025-06-03 | Becton Dickinson Infusion Therapy Syst… | BD Nexiva Diffusics Closed IV Catheter System and … | |
| K243105 | 2025-05-16 | Venocare, Inc. | Ruby Intravascular Catheter | |
| K250292 | 2025-05-02 | Skydance Vascular, Inc. | OSPREY Midline Closed IV Catheter System (OspreyEDC… | |
| K244059 | 2025-03-27 | Access Vascular, Inc. | HydroMID 5F Dual Lumen Midline Catheter - Basic Kit … | |
| K243599 | 2025-03-14 | Arrow International, LLC (A subsidiary… | Arrow Endurance Extended Dwell Peripheral Catheter… | |
| K242281 | 2024-12-20 | Arrow International, LLC (A subsidiary… | Arrow Endurance Extended Dwell Peripheral Catheter S… | |
| K241115 | 2024-11-27 | Spectrum Vascular | SV Spectrum MRC Central Venous Catheter; SV Spectrum… | |
| K240359 | 2024-07-29 | Becton, Dickinson and Company (Bard Ac… | PowerGlide Pro Midline Catheter | |
| K241845 | 2024-07-26 | B.Braun Medical, Inc. | Introcan Safety® 2 IV Catheter | |
| K233106 | 2024-04-19 | Bard Access Systems, Inc. (C.R. Bard, … | AccuCath Ace Intravascular Catheter | |
| K232234 | 2024-03-15 | Poly Medicure Limited | Nouvo Safety Set | FDA |
| K233529 | 2023-12-01 | Becton Dickinson Infusion Therapy Syst… | BD Nexiva Diffusics Closed IV Catheter System with… | |
| K231239 | 2023-09-22 | Becton Dickinson Infusion Therapy Syst… | Nexiva Closed IV Catheter System with NearPort IV … | |
| K231401 | 2023-09-21 | Poly Medicure Limited | Polysafety BC, Polysafety BC Adva, Polywin Safety, P… | |
| K223788 | 2023-09-15 | Medsource International, LLC | The MedSource TrueSafe Blood Control I.V. Safety Cat… |
Official FDA classification page: FOZ
Classification and pathway per current FDA publications. Data from openFDA (CC0).