Atlas FDA

SHILEY PREBYPASS FILTER

FDA 510(k) clearance K840450 · decided 1984-04-17

Clearance details

K-number
K840450
Device name
SHILEY PREBYPASS FILTER
Applicant
Shiley, Inc.
Decision
Substantially Equivalent
Date received
1984-02-01
Decision date
1984-04-17
Days to decision
76 days
Clearance type
Traditional
Product code
KRJ
Device class
2
Regulation number
870.4280
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Mchenry, IL, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
POROUS MEDIA DPB30 SERIES DISPOSABLE PRE-BYPASS FILTER (K990276)Porous Media Corp.1999-10-01
POROUS MEDIA DPB20 SERIES DISPOSABLE PRE-BYPASS FILTER (K982385)Porous Media Corp.1999-02-01
AVECOR PRE-BYPASS FILTER (K940126)Avecor Cardiovascular, Inc.1994-06-28
PREBYPASS FILTER, CAT. NO. FPB-5 (K900672)American Omni Medical, Inc.1990-04-03
INTERSEPT* CRYSTALLOID CARDIOPLEGIA DELIV. SYSTEM (K885154)Medtronic Blood Systems, Inc.1989-02-22
INTERSEPT* CRYSTALLOID CARDIOPLEGIA FILTER (K884390)Medtronic Blood Systems, Inc.1988-12-21
INTERSEPT* PREBYPASS FILTER (K884244)Medtronic Blood Systems, Inc.1988-12-05
INTERSEPT*PREBYPASS FILTER (K883086)Medtronic Blood Systems, Inc.1988-09-16
ULTIPOR PRE-BYPASS PLUS FILTER W/POSIDYNE MEMBRANE (K875094)Pall Biomedical Products Co.1988-02-29
PREBYPASS FILTER (K871350)American Omni Medical, Inc.1987-06-08
INTERFACE CRYSTALLOID CARDIOPLEGIC FILTER MODEL 70 (K861226)Medical, Inc.1986-06-02
COBE COP FILTER CARDIOPULMONARY PREBYPASS FILTER (K850139)Rapid Diagnostic Laboratories, Inc.1985-04-10

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
BJORK-SHILEY CARDIAC VALVE (P780008/S013)Shiley, Inc.1986-10-31
BJORK-SHILEY CARDIAC VALVE (P780008/S014)Shiley, Inc.1985-04-09
BJORK-SHILEY CARDIAC VALVE (P780008/S015)Shiley, Inc.1984-11-26
BJORK-SHILEY CARDIAC VALVE (P780008/S011)Shiley, Inc.1984-05-15
BJORK-SHILEY CARDIAC VALVE (P780008/S007)Shiley, Inc.1983-05-20
BJORK-SHILEY CARDIAC VALVE (P780008/S005)Shiley, Inc.1982-02-05