FOZ — Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days Class II
FDA product code FOZ covers "Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days", a Class II medical device regulated under 21 CFR 880.5200. Submissions are reviewed by the General Hospital panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- FOZ
- Device Class
- Class II
- Regulation Number
- 880.5200
- Submission Type
- Review Panel
- HO
- Medical Specialty
- General Hospital
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K261041 | medsource labs | ClearSafe Closed System | July 10, 2026 |
| K260539 | medsource labs | MedSource QuickSafe Safety IV Catheter; MedSource PurSafe Safety IV Catheter | July 9, 2026 |
| K253235 | b.braun medical | Introcan Safety® Deep Access XL IV Catheter | May 15, 2026 |
| K252137 | becton dickinson infusion therapy systems | BD Insyte IV Catheter | April 2, 2026 |
| K252513 | poly medicure limited | Polywin Safety (14G x 51mm; 16G x 51mm; 18G x 64mm; 20G x 64mm; 20G x 45mm; 22G | April 1, 2026 |
| K252398 | terumo medical products (hangzhou) co | SURFLO Hybria Closed System Safety IV Catheter | December 17, 2025 |
| K252677 | poly medicure limited | Polyshield Safety IV Catheters | November 5, 2025 |
| K251422 | becton dickinson infusion therapy systems | BD Saf-T-Intima Subcutaneous Catheter System | October 8, 2025 |
| K243403 | becton dickinson infusion therapy systems | BD Nexiva Closed IV Catheter System | July 25, 2025 |
| K251155 | becton dickinson infusion therapy systems | BD Cathena Safety IV Catheter | July 11, 2025 |
| K251654 | becton dickinson infusion therapy systems | BD Insyte Autoguard Shielded IV Catheter, BD Insyte Autoguard BC Shielded IV | June 27, 2025 |
| K250682 | becton dickinson infusion therapy systems | BD Nexiva Diffusics Closed IV Catheter System and BD Nexiva Diffusics Closed | June 3, 2025 |
| K243105 | venocare | Ruby Intravascular Catheter | May 16, 2025 |
| K250292 | skydance vascular | OSPREY Midline Closed IV Catheter System (OspreyEDC-F20) | May 2, 2025 |
| K244059 | access vascular | HydroMID 5F Dual Lumen Midline Catheter - Basic Kit (70006102); HydroMID 5F Dual | March 27, 2025 |
| K243599 | arrow international, llc (a subsidiary of teleflex, inc.) | Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00818) | March 14, 2025 |
| K242281 | arrow international, llc (a subsidiary of teleflex, inc.) | Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00620); Arrow End | December 20, 2024 |
| K241115 | spectrum vascular | SV Spectrum MRC Central Venous Catheter; SV Spectrum MR Central Venous Catheter; | November 27, 2024 |
| K240359 | becton, dickinson and company (bard access systems, inc.) | PowerGlide Pro Midline Catheter | July 29, 2024 |
| K241845 | b.braun medical | Introcan Safety® 2 IV Catheter | July 26, 2024 |