FDA.reportPublic FDA data

510(k) K831458

Device
CARDIOPLEGIA RECIRCULATION SYS-BL 705/A
Applicant
ELECTROMEDICS, INC.
510(k) number
K831458
Product code
DWB  
Decision
Substantially Equivalent (SESE)
Decision date
1983-10-20
Date received
1983-05-06
Regulation
870.4370
Classification name
Pump, Blood, Cardiopulmonary Bypass, Roller Type
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
4221 Richmond Rd., NW Walker MI US 49534 49534

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code DWB  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K162843Small (4) Roller Pump for the Terumo Advanced Perfusion System 1, Large (6) Roller Pump for the Terumo Advanced Perfusion System 1Terumo Cardiovascular Systems Corporation2016-11-17
K131618LARGE (6) ROLLER PUMP FOR TERUMO ADVANCED PERFUSION SYSTEM 1; LARGE (6) ROLLER PUMP FOR TERUMO ADVANCED PERFUSION SYSTTerumo Cardiovascular Systems Corporation2013-09-27
K112587ADVANCED PERFUSION SYSTEM 1 (APS1) TUBE CLAMP ASSEMBLY, ROLLER PUMP 6 INCH CLASSIC COLOR,Terumo Cardiovascular Systems Corp.2011-12-19
K973237CSS-CARDIOPLEGIA SAFETY SYSTEMMedtronic Bio-Medicus, Inc.1998-04-27
K972321S3 MAST PUMPStoeckert Instrumente1998-02-27
K971520S3 CYCLIC RPM CONTROLStoeckert Instrumente1997-09-10
K960974COBE CENTURY PERFUSION PUMPCobe Cardiovascular, Inc.1997-07-14
K953901SARNS 800 ROLLER PUMP3M Health Care, Sarns1996-04-19
K953904SARNS 9000 UNIVERSAL ROLLER PUMP3M Health Care, Ltd.1996-04-19
K955038STOCKERT S3 DOUBLE HEAD PUMP MODULEStoeckert Instrumente1996-02-21
K890904MODIFIED STOCKERT-SHILEY CAPS MULTI. ROLLER PUMPShiley, Inc.1989-04-12
K881780VASCUCARE ANGIOPUMPVascucare, Inc.1988-09-28
K874771ANGIOMED INTRODUCING SETSAngiomed U.S., Inc.1988-01-12
K861714STOCKERT-SHILEY MULTIFLOW ROLLER PUMP MODULEShiley, Inc.1986-07-16
K862116STOCKERT-SHILEY DOUBLE HEAD PUMP MODULEShiley, Inc.1986-07-16

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