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510(k) K840450

Device
Shiley Prebypass Filter
Applicant
SHILEY, INC.
510(k) number
K840450
Product code
KRJ
Decision
Substantially Equivalent (SESE)
Decision date
1984-04-17
Date received
1984-02-01
Regulation
870.4280
Classification name
Filter, Prebypass, 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 KRJ#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K990276POROUS MEDIA DPB30 SERIES DISPOSABLE PRE-BYPASS FILTERPorous Media Corp.1999-10-01
K982385POROUS MEDIA DPB20 SERIES DISPOSABLE PRE-BYPASS FILTERPorous Media Corp.1999-02-01
K940126AVECOR PRE-BYPASS FILTERAvecor Cardiovascular, Inc.1994-06-28
K900672PREBYPASS FILTER, CAT. NO. FPB-5American Omni Medical, Inc.1990-04-03
K885154INTERSEPT* CRYSTALLOID CARDIOPLEGIA DELIV. SYSTEMMedtronic Blood Systems, Inc.1989-02-22
K884390INTERSEPT* CRYSTALLOID CARDIOPLEGIA FILTERMedtronic Blood Systems, Inc.1988-12-21
K884244INTERSEPT* PREBYPASS FILTERMedtronic Blood Systems, Inc.1988-12-05
K883086INTERSEPT*PREBYPASS FILTERMedtronic Blood Systems, Inc.1988-09-16
K875094ULTIPOR PRE-BYPASS PLUS FILTER W/POSIDYNE MEMBRANEPall Biomedical Products Co.1988-02-29
K871350PREBYPASS FILTERAmerican Omni Medical, Inc.1987-06-08
K861226INTERFACE CRYSTALLOID CARDIOPLEGIC FILTER MODEL 70Medical, Inc.1986-06-02
K850139COBE COP FILTER CARDIOPULMONARY PREBYPASS FILTERRapid Diagnostic Laboratories, Inc.1985-04-10
K842141SOLUTION CLARIFICATION UNITPall Biomedical Products Co.1984-08-03
K832594PRE-BYPASS FILTER #EC-PBF SERIESGish Biomedical, Inc.1983-09-20
K831286ULTIPORE PREBYPASS PLUS FILTERPall Biomedical Products Co.1983-06-08