FDA.reportPublic FDA data

510(k) K880006

Device
STA-SET I.V. FLOW REGULATOR
Applicant
CONTROLLED FLOW LTD.
510(k) number
K880006
Product code
LDR  
Decision
Substantially Equivalent (SESE)
Decision date
1988-03-24
Date received
1988-01-04
Regulation
880.5725
Classification name
Controller, Infusion, Intravascular, Electronic
Medical specialty
General Hospital
Review panel
General Hospital
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
MATTHEW O'BOYLE
Address
12705 S. Kirkwood 220 Stafford TX US 77477 77477

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code LDR  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K242693DEKA Infusion System, DEKA Administration SetDeka Research and Development Corporation2024-10-07
K232316DEKA Infusion System, DEKA Administration SetDeka Research and Development2024-03-01
K153760Volumetric Infusion ControllerDEKA Research & Development2016-10-03
K963136PACER MODEL 100 INFUSION CONTROLLERHealth Watch, Inc.1997-10-10
K971865ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M12/500-3PAlexander Mfg. Co.1997-07-03
K971826ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M12/500Alexander Mfg. Co.1997-07-03
K934543UNIVERSAL CONTROLLER, MODEL 100Metamed, Inc.1994-03-29
K935236FLOW CONTROLLING EXTENSION SETBlock Medical, Inc.1994-02-24
K905498STAT 2 IV PUMPETTEThe Master Medical Corp.1991-04-16
K905497MASTER FLOW I.V. PUMPETTEThe Master Medical Corp.1991-04-16
K8969073M IV FLOW REGULATOR3M Company1990-02-26
K894111VARI-SETSonex Medical1989-09-28
K894487IVAC(R) VOLUMETRIC CONTROLLER - MODEL 262+Y1989-09-27
K893487LIFECARE 75 CONTROLLERAbbott Laboratories1989-07-28
K884307IVAC(R) VOLUMETRIC CONTROLLER - MODEL 262Y1988-11-01

Legacy Summary#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases