510(k) K122544
- Device
- TERUMO SURFLASH SAFETY I.V. CATHETER
- Applicant
- TERUMO Corporation
- 510(k) number
- K122544
- Product code
- FOZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2012-09-05
- Date received
- 2012-08-21
- Regulation
- 880.5200
- Classification name
- Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- Yes
Applicant Contact#
- Contact
- SANDI HARTKA
- Address
- 1727-1, Tsuijiarai, Showa-Cho Nakakoma-Gun Yamanashi JP 409-3853 409-3853
FDA Registration Numbers#
- 2527072
- 1123137
- 3009750712
- 3009211636
- 3032916632
- 3030626857
- 1647137
- 1018233
- 9680794
- 3007616112
- 3018507299
- 1625425
- 2011171
- 9612030
- 3003775072
- 1061124
- 9680143
- 3012307300
- 3010041511
- 3005246939
- 3005515211
- 3013162291
- 1219611
- 3010131137
- 9610847
- 3002807350
- 3015859709
- 9611446
- 3015173212
- 3004111573
- 3012536737
- 2030624
- 8020785
- 3012026312
- 3004519921
- 3033589330
- 3004102031
- 3010055973
- 3003895440
- 3036773433
- 3013764800
- 1064858
- 3010220595
- 3001124136
- 2320762
- 8010026
- 2245270
- 1054241
- 3014389131
- 3021570645
- 8041187
- 3004187702
- 3017509841
- 1710034
- 3003916417
- 3002601200
- 9617594
- 3004785273
- 3031983053
- 3008307705
- 3012187635
- 2024024
- 9615588
- 3004129394
- 3007207906
- 3006942602
- 1928237
- 3006260740
- 3015309643
- 3003442380
- 3002807090
- 3014663754
- 1319639
- 3043226252
- 2024311
- 3010419931
- 9610825
- 9615908
- 3004784537
- 8043983
Source Documents#
Other 510(k) Records For Product Code FOZ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253235 | Introcan Safety® Deep Access XL IV Catheter | B.Braun Medical, Inc. | 2026-05-15 |
| K252137 | BD Insyte™ IV Catheter | Becton Dickinson Infusion Therapy Systems, Inc. | 2026-04-02 |
| 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 |
| K252398 | SURFLO Hybria Closed System Safety IV Catheter | Terumo Medical Products (Hangzhou) Co., Ltd. | 2025-12-17 |
| K252677 | Polyshield Safety IV Catheters | Poly Medicure Limited | 2025-11-05 |
| K251422 | BD Saf-T-Intima™ Subcutaneous Catheter System | Becton Dickinson Infusion Therapy Systems, Inc. | 2025-10-08 |
| K243403 | BD Nexiva™ Closed IV Catheter System | Becton Dickinson Infusion Therapy Systems, Inc. | 2025-07-25 |
| K251155 | BD Cathena™ Safety IV Catheter | Becton Dickinson Infusion Therapy Systems, Inc. | 2025-07-11 |
| 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 |
| 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 |
| K243105 | Ruby Intravascular Catheter | Venocare, Inc. | 2025-05-16 |
| K250292 | OSPREY Midline Closed IV Catheter System (OspreyEDC-F20) | Skydance Vascular, Inc. | 2025-05-02 |
| 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 |
| K243599 | Arrow™ Endurance™ Extended Dwell Peripheral Catheter System (EDC-00818) | Arrow International, LLC (A subsidiary of Teleflex, Inc.) | 2025-03-14 |
| 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 |
Legacy Summary#
summary
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases