Chrysalis Intelligence · Product Codes · FOZ

FOZ · Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days

General Hospital · 54 clearances · 25 unique sponsors

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Device class
Class II
Regulation 880.5200
Total clearances
54
2020-01-24 → 2026-08-10
Last 12 months
9
Unique sponsors
25
Classification details
Medical specialty
General Hospital
Review panel
HO
Regulation number
880.5200
Implant
N
Life-sustain / support
N
GMP exempt
N
Third-party review
Y
Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor Clearances Last 12 mo Most recent
Becton Dickinson Infusion Therapy Systems, Inc. 11 2 2026-04-02
B.Braun Medical, Inc. 7 1 2026-05-15
Poly Medicure Limited 5 2 2026-04-01
Access Vascular, Inc. 3 0 2025-03-27
Skydance Vascular, Inc. 3 0 2025-05-02
Medsource Labs 3 2 2026-07-10
Becton, Dickinson and Company 2 0 2021-06-02
Arrow International, LLC (A subsidiary of Teleflex, Inc.) 2 0 2025-03-14
Spectrum Vascular 2 1 2026-08-10
Vygon USA 1 0 2022-08-29
Becton, Dickinson and Company (Bard Access Systems, Inc.) 1 0 2024-07-29
Venocare, Inc. 1 0 2025-05-16
Medsource International, LLC 1 0 2023-09-15
Bard Access Systems, Inc. (Bard Has Joined Bd) 1 0 2020-04-07
Global Medikit Limited 1 0 2020-11-24
Delta Med Spa 1 0 2020-08-26
Cook Advanced Technologies 1 0 2023-02-03
Woo Young Medical Co., Ltd. 1 0 2022-09-13
Mediplus (India) Limited 1 0 2022-03-25
Bard Access Systems, Inc. (C.R. Bard, Inc.) 1 0 2024-04-19
Health Line International Corporation 1 0 2020-03-12
Saudi Mais Co. For Medical Products 1 0 2023-06-23
Terumo Medical Products (Hangzhou) Co., Ltd. 1 1 2025-12-17
Shinva Ande Healthcare Apparatus Co., Ltd. 1 0 2021-07-23
Medifirst Co., Ltd. 1 0 2020-04-23
Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

CodeTypeDescriptionConfidenceRationale
36000 CPT — High Introduction of needle or intracatheter, vein
36010 CPT — Medium Therapeutic drug injection via therapeutic intracatheter
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2026-08-10 K260165 Spectrum Vascular Unimpregnated Central Venous Catheter
2026-07-10 K261041 MedSource Labs, LLC ClearSafe Closed System
2026-07-09 K260539 MedSource Labs, LLC MedSource QuickSafe™ Safety IV Catheter; MedSource PurSafe™ Safety IV Catheter
2026-05-15 K253235 B.Braun Medical, Inc. Introcan Safety® Deep Access XL IV Catheter
2026-04-02 K252137 Becton Dickinson Infusion Therapy Systems, Inc. BD Insyte™ IV Catheter
2026-04-01 K252513 Poly Medicure Limited 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)
2025-12-17 K252398 Terumo Medical Products (Hangzhou) Co., Ltd. SURFLO Hybria Closed System Safety IV Catheter
2025-11-05 K252677 Poly Medicure Limited Polyshield Safety IV Catheters
2025-10-08 K251422 Becton Dickinson Infusion Therapy Systems, Inc. BD Saf-T-Intima™ Subcutaneous Catheter System
2025-07-25 K243403 Becton Dickinson Infusion Therapy Systems, Inc. BD Nexiva™ Closed IV Catheter System
2025-07-11 K251155 Becton Dickinson Infusion Therapy Systems, Inc. BD Cathena™ Safety IV Catheter
2025-06-27 K251654 Becton Dickinson Infusion Therapy Systems, Inc. BD Insyte™ Autoguard™ Shielded IV Catheter, BD Insyte™ Autoguard™ BC Shielded IV Catheter and BD Insyte™ Autoguard™ BC Pro Shielded IV Catheter
2025-06-03 K250682 Becton Dickinson Infusion Therapy Systems, Inc. BD Nexiva™ Diffusics™ Closed IV Catheter System and BD Nexiva™ Diffusics™ Closed IV Catheter System with BD MaxZero™ Needle-free Connector
2025-05-16 K243105 Venocare, Inc. Ruby Intravascular Catheter
2025-05-02 K250292 Skydance Vascular, Inc. OSPREY Midline Closed IV Catheter System (OspreyEDC-F20)
2025-03-27 K244059 Access Vascular, Inc. 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)
2025-03-14 K243599 Arrow International, LLC (A subsidiary of Teleflex, Inc.) Arrow™ Endurance™ Extended Dwell Peripheral Catheter System (EDC-00818)
2024-12-20 K242281 Arrow International, LLC (A subsidiary of Teleflex, Inc.) 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)
2024-11-27 K241115 Spectrum Vascular SV Spectrum MRC Central Venous Catheter; SV Spectrum MR Central Venous Catheter; SV Central Venous Catheter
2024-07-29 K240359 Becton, Dickinson and Company (Bard Access Systems, Inc.) PowerGlide Pro™ Midline Catheter
2024-07-26 K241845 B.Braun Medical, Inc. Introcan Safety® 2 IV Catheter
2024-04-19 K233106 Bard Access Systems, Inc. (C.R. Bard, Inc.) AccuCath Ace™ Intravascular Catheter
2024-03-15 K232234 Poly Medicure Limited Nouvo Safety Set
2023-12-01 K233529 Becton Dickinson Infusion Therapy Systems, Inc. BD Nexiva™ Diffusics™ Closed IV Catheter System with BD MaxZero™ Needle-free Connector
2023-09-22 K231239 Becton Dickinson Infusion Therapy Systems, Inc. Nexiva™ Closed IV Catheter System with NearPort™ IV Access
Data source: openFDA · Generated 2026-08-28 09:16 · Last ingest 2026-08-28T13:16:47.116226 · Pipeline: Chrysalis Intelligence