510(k) K241115
- Device
- SV Spectrum MRC Central Venous Catheter; SV Spectrum MR Central Venous Catheter; SV Central Venous Catheter
- Applicant
- Spectrum Vascular
- 510(k) number
- K241115
- Product code
- FOZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-11-27
- Date received
- 2024-04-23
- 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
- N
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Related Records
Applicant Contact
- Contact
- Sharon Klugewicz
- Address
- 50 Main St. Suite 1000 White Plains NY US 10606 10606
FDA Registration Numbers
- 3013517171
- 3036773433
- 9610048
- 3002807090
- 3004134316
- 3031983053
- 1423507
- 9617592
- 1061124
- 3011689956
- 3008307705
- 9681835
- 8041145
- 3037918935
- 3012536737
- 3013188547
- 9615908
- 3010882065
- 1035907
- 1644312
- 2032098
- 3006260740
- 1018470
- 3012809732
- 3005246939
- 3021570645
- 3002807350
- 3022518300
- 3006621386
- 3010055973
- 8043983
- 9616991
- 3015997711
- 3001124136
- 3013557562
- 2246552
- 3010131137
- 3011241266
- 3012026312
- 1423537
- 1721676
- 1000163068
- 1820334
- 3006425876
- 3006950086
- 3012307300
- 3033589330
- 3013162291
- 3013298431
- 1824619
- 3000247873
- 3003915875
- 1064858
- 2024024
- 3002807314
- 1018233
- 3008403546
- 9680143
- 3003674698
- 3010384323
- 3030733800
- 3033536319
- 9611446
- 3005515211
- 3009758019
- 8021545
- 1422634
- 1625425
- 3014656749
- 3012542015
- 3030626857
- 1043214
- 3035111606
- 9612086
- 1055236
- 3012421607
- 3030714660
- 3013319212
- 1219611
- 3015173212
Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON
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 |