510(k) K013556
- Device
- MONOJECT PREFILL HEPARIN LOCK FLUSH SYRINGE
- Applicant
- TYCO HEALTHCARE
- 510(k) number
- K013556
- Product code
- FOZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2001-12-31
- Date received
- 2001-10-25
- 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
- No
Applicant Contact#
- Contact
- DAVID A OLSON
- Address
- 15 Hampshire St. Mansfield MA US 02048 02048
FDA Registration Numbers#
- 1282497
- 2523676
- 1422634
- 3003902955
- 3010621964
- 3010384323
- 3003442380
- 3004187702
- 2024311
- 3014663754
- 9616157
- 3003775072
- 1056186
- 1035907
- 1710034
- 9610825
- 3013319212
- 1055927
- 3015997711
- 3004102031
- 2032112
- 3030574705
- 3022054170
- 3005246939
- 3015724078
- 3006846316
- 3013517171
- 1820334
- 3008307705
- 3010220595
- 3030733800
- 3036773433
- 1721686
- 3008410596
- 3033536319
- 3010419931
- 1123137
- 3012050423
- 3016904853
- 3001124136
- 3030714660
- 1721676
- 3013162291
- 2243072
- 3012039263
- 3002807314
- 3037918935
- 3012307300
- 2032098
- 8041187
- 3013298431
- 3031233007
- 1054241
- 1713468
- 3005609751
- 9680143
- 9610987
- 3009888344
- 3014656749
- 3016727301
- 1647137
- 8020785
- 3009211636
- 3004134316
- 9616088
- 1018470
- 3013188547
- 3010754844
- 3003915875
- 1018233
- 9681835
- 2518902
- 3010421104
- 1644312
- 9616991
- 3043226252
- 8010026
- 2024024
- 3002807090
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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