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510(k) K830634

Device
CARDIOTOMY FILTER
Applicant
TEXAS MEDICAL PRODUCTS, INC.
510(k) number
K830634
Product code
JOD  
Decision
Substantially Equivalent (SESE)
Decision date
1983-06-30
Date received
1983-03-01
Regulation
870.4270
Classification name
Filter, Blood, Cardiotomy Suction Line, Cardiopulmonary Bypass
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code JOD  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K993060GAS FILTEROlson Medical Sales, Inc.2000-03-28
K890504CARDIOTOMY/AUTOTRANSFUSION/PLEURAL DRAINAGE VENOUSGish Biomedical, Inc.1989-03-10
K875095PALL CARDIOPLEGIA PLUS FILTER W/POSIDYNE MEMBRANEPall Biomedical Products Co.1988-02-29
K874405PALL STAT PRIME(TM) BLOOD FILTER FOR EXTRA. USEPall Biomedical Products Co.1987-12-30
K855067SWANK CARDIOTOMY SUCTION LINE BLOOD FILTER CA100Cobe Laboratories, Inc.1986-02-26
K841958CARDIO METRICS CARDIOTOMY RESERVOIRSterile Design, Inc.1984-10-15
K823259INTERFACE CARDIOTOMY BLOOD FILTER #50Medical, Inc.1982-11-24
K823260INTERFACE CARDIOTOMY BLOOD FILTER #51Medical, Inc.1982-11-24
K812243INTERFACE CARDIOTOMY BLOOD FILTER #51Medical, Inc.1981-08-25
K781383INTERFACE CARDIOTOMY BLOOD FILTERMedical, Inc.1978-09-27
K780653EXTRACORPEAL CARDIOTOMY BLOOD FILTERCobe Laboratories, Inc.1978-06-14

Legacy Summary#

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FDA Review#

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