510(k) K980566
- Device
- VAXESS PERIPHERALLY INSERTED CENTRAL CATHETER
- Applicant
- BOSTON SCIENTIFIC CORP.
- 510(k) number
- K980566
- Product code
- FOZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1998-09-14
- Date received
- 1998-02-13
- 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
- WANDA M CARPINELLA
- Address
- One Boston Scientific Pl. Natick, MA US 01760 01760
FDA Registration Numbers#
- 3000247873
- 1000563940
- 3015173212
- 3012050423
- 9617594
- 3008496528
- 1423537
- 2024311
- 3006425876
- 2024024
- 3003674698
- 8041145
- 3014656749
- 3004102031
- 3010532612
- 9616991
- 3031233007
- 3011088743
- 3036773433
- 3033536319
- 3002807314
- 3010882065
- 3030574705
- 1625425
- 9611446
- 3010934635
- 8020616
- 9612126
- 3011237770
- 2025816
- 3015997711
- 9617604
- 3004785273
- 3006260740
- 3013162291
- 2032112
- 9616088
- 2011171
- 3004784537
- 3010384323
- 3003895440
- 1319639
- 1018233
- 1054241
- 3022728142
- 1928237
- 3002807350
- 9680143
- 3011241266
- 3003915875
- 3002807090
- 1423507
- 3010413216
- 1018470
- 3007616112
- 1064858
- 1410248
- 3000268902
- 9681835
- 1721686
- 2245270
- 9610847
- 3013188547
- 9615908
- 9610825
- 3004519921
- 1220477
- 3010220595
- 8020889
- 3031983053
- 3010055973
- 2029015
- 1921846
- 3010754844
- 1422634
- 1123137
- 3008307705
- 3013764800
- 1055236
- 3006942602
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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