510(k) K082997
- Device
- TERUMO HYBRIA CLOSED SYSTEM SAFETY I.V. CATHETER
- Applicant
- TERUMO MEDICAL CORP.
- 510(k) number
- K082997
- Product code
- FOZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2009-04-15
- Date received
- 2008-10-08
- 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
- EILEEN DORSEY
- Address
- 950 Elkton Blvd. Elkton MD US 21921 21921
FDA Registration Numbers#
- 3010532612
- 3008410596
- 3006082230
- 3008496528
- 3012421607
- 3010220595
- 3016678045
- 3004519921
- 3030446844
- 3013162291
- 3012307300
- 3000247873
- 3020460367
- 3003442380
- 3006425876
- 9617592
- 3002807350
- 9680794
- 3004111573
- 3012536737
- 1824619
- 9610987
- 3004102031
- 9615908
- 2011171
- 2518902
- 3010413216
- 3010934635
- 8043983
- 3012542015
- 3043226252
- 9617604
- 9616088
- 3006942602
- 3003895440
- 3030733800
- 1647137
- 3011137372
- 3012809732
- 3021570645
- 3011689956
- 1043214
- 3005246939
- 8020616
- 3004187702
- 3008403546
- 3000268902
- 2648045
- 3007836437
- 1713468
- 3036773433
- 3004784537
- 3018507299
- 3011237770
- 3014579161
- 1319211
- 3016904853
- 3010041511
- 3010621964
- 2032098
- 9616157
- 1056186
- 9610825
- 3013517171
- 3010754844
- 1319639
- 2246552
- 2024024
- 1018470
- 1054241
- 3010882065
- 3008307705
- 9610849
- 3009291251
- 9612433
- 1721676
- 3015058854
- 3042370483
- 3015997711
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#
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