510(k) K895110

Device
MAESTRO PACEMAKER TEST MAGNET
Applicant
CARDIAC CONTROL SYSTEMS, INC.
510(k) number
K895110
Product code
DTG  
Decision
Substantially Equivalent (SESE)
Decision date
1989-09-26
Date received
1989-08-15
Regulation
870.3690
Classification name
Magnet, Test, Pacemaker
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
SCOTT MINDREBO
Address
3 Commerce Blvd. Palm Coast FL US 32164 32164

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code DTG  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K092364MODEL 220 PATIENT MAGNETCyberonics, Inc.2009-11-03
K960849MAGNO ALARMCardiac Assist Devices, Inc.1997-03-26
K831926IMPLANTABLE ENDOCARDIAL PACING LEADSOscor, Inc.1984-03-12
K813153TEST MAGNETPacesetter Systems1981-12-02

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