FDA.report

510(k) K021557

Device
SPECTRUM SILICONE CATHETER
Applicant
COOK, INC.
510(k) number
K021557
Product code
FOZ  
Decision
Substantially Equivalent (SESE)
Decision date
2003-05-30
Date received
2002-05-13
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
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
APRIL LAVENDER
Address
925 S. Curry Pike P.O. Box 489 Bloomington IN US 47402 47402

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

Other 510(k) Records For Product Code FOZ  

510(k)DeviceApplicantDecision date
K253235Introcan Safety® Deep Access XL IV CatheterB.Braun Medical, Inc.2026-05-15
K252137BD Insyte™ IV CatheterBecton Dickinson Infusion Therapy Systems, Inc.2026-04-02
K252513Polywin 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 Limited2026-04-01
K252398SURFLO Hybria Closed System Safety IV CatheterTerumo Medical Products (Hangzhou) Co., Ltd.2025-12-17
K252677Polyshield Safety IV CathetersPoly Medicure Limited2025-11-05
K251422BD Saf-T-Intima™ Subcutaneous Catheter SystemBecton Dickinson Infusion Therapy Systems, Inc.2025-10-08
K243403BD Nexiva™ Closed IV Catheter SystemBecton Dickinson Infusion Therapy Systems, Inc.2025-07-25
K251155BD Cathena™ Safety IV CatheterBecton Dickinson Infusion Therapy Systems, Inc.2025-07-11
K251654BD Insyte™ Autoguard™ Shielded IV Catheter, BD Insyte™ Autoguard™ BC Shielded IV Catheter and BD Insyte™ Autoguard™ BC Pro Shielded IV CatheterBecton Dickinson Infusion Therapy Systems, Inc.2025-06-27
K250682BD Nexiva™ Diffusics™ Closed IV Catheter System and BD Nexiva™ Diffusics™ Closed IV Catheter System with BD MaxZero™ Needle-free ConnectorBecton Dickinson Infusion Therapy Systems, Inc.2025-06-03
K243105Ruby Intravascular CatheterVenocare, Inc.2025-05-16
K250292OSPREY Midline Closed IV Catheter System (OspreyEDC-F20)Skydance Vascular, Inc.2025-05-02
K244059HydroMID 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
K243599Arrow™ Endurance™ Extended Dwell Peripheral Catheter System (EDC-00818)Arrow International, LLC (A subsidiary of Teleflex, Inc.)2025-03-14
K242281Arrow 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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