510(k) K082362
- Device
- SURSHIELD SAFETY I.V. CATHETER
- Applicant
- TERUMO MEDICAL CORP.
- 510(k) number
- K082362
- Product code
- FOZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2008-09-17
- Date received
- 2008-08-18
- 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#
- 2518902
- 1644312
- 2024311
- 1282497
- 1713468
- 3008307705
- 3022054170
- 1319639
- 2320762
- 1054241
- 3015859709
- 3011088743
- 3004784537
- 3012187635
- 1000563940
- 3006425876
- 3006942602
- 3003915875
- 3003442380
- 1223004
- 3005609751
- 3005956311
- 3015173212
- 3015058854
- 9610847
- 3003674698
- 3010934635
- 3008496528
- 9616088
- 3014656749
- 3006082230
- 3017129766
- 9612030
- 9681835
- 3005941719
- 3003895440
- 3030626857
- 3010419931
- 3031233007
- 3009211636
- 3003775072
- 1721676
- 8043983
- 8021545
- 9610987
- 3010754844
- 9616157
- 1422634
- 3004785273
- 1055236
- 3014389131
- 1064858
- 2025816
- 3000247873
- 2032098
- 9616567
- 3010621964
- 3012104670
- 9615588
- 1055927
- 1319211
- 3010220595
- 3014270673
- 1647137
- 2243072
- 3004111573
- 3013319212
- 1423507
- 9612126
- 1410248
- 3033536319
- 3000268902
- 3010384323
- 3013764800
- 9610825
- 3006846316
- 3015997711
- 3004122598
- 9617594
Source Documents#
Other 510(k) Records For Product Code FOZ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261041 | ClearSafe Closed System | MedSource Labs, LLC | 2026-07-10 |
| K260539 | MedSource QuickSafe™ Safety IV Catheter; MedSource PurSafe™ Safety IV Catheter | MedSource Labs, LLC | 2026-07-09 |
| 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 |
Legacy Summary#
summary
FDA Review#
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