Product code KRJ— Cardiovascular

FDA has cleared 24 devices under product code KRJ between 1978 and 1999, filed by 13 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

• 19992 clearances
• 19941 clearance
• 19901 clearance
• 19891 clearance
• 19884 clearances
• 19871 clearance
• 19861 clearance
• 19851 clearance
• 19842 clearances
• 19832 clearances
• 19814 clearances
• 19802 clearances
• 19791 clearance
• 19781 clearance

• Medtronic Blood Systems, Inc.4 clearances
• Pall Biomedical Products Co.3 clearances
• Medical, Inc.3 clearances
• Porous Media Corp.2 clearances
• Delta Medical Industries2 clearances
• Bentley Laboratories, Inc.2 clearances
• American Omni Medical, Inc.2 clearances
• Texas Medical Products, Inc.1 clearance
• Shiley, Inc.1 clearance
• Rapid Diagnostic Laboratories, Inc.1 clearance

• K990276 — POROUS MEDIA DPB30 SERIES DISPOSABLE PRE-BYPASS FILTERPorous Media Corp.·1999-10-01
• K982385 — POROUS MEDIA DPB20 SERIES DISPOSABLE PRE-BYPASS FILTERPorous Media Corp.·1999-02-01
• K940126 — AVECOR PRE-BYPASS FILTERAvecor Cardiovascular, Inc.·1994-06-28
• K900672 — PREBYPASS FILTER, CAT. NO. FPB-5American Omni Medical, Inc.·1990-04-03
• K885154 — INTERSEPT* CRYSTALLOID CARDIOPLEGIA DELIV. SYSTEMMedtronic Blood Systems, Inc.·1989-02-22
• K884390 — INTERSEPT* CRYSTALLOID CARDIOPLEGIA FILTERMedtronic Blood Systems, Inc.·1988-12-21
• K884244 — INTERSEPT* PREBYPASS FILTERMedtronic Blood Systems, Inc.·1988-12-05
• K883086 — INTERSEPT*PREBYPASS FILTERMedtronic Blood Systems, Inc.·1988-09-16
• K875094 — ULTIPOR PRE-BYPASS PLUS FILTER W/POSIDYNE MEMBRANEPall Biomedical Products Co.·1988-02-29
• K871350 — PREBYPASS FILTERAmerican Omni Medical, Inc.·1987-06-08
• K861226 — INTERFACE CRYSTALLOID CARDIOPLEGIC FILTER MODEL 70Medical, Inc.·1986-06-02
• K850139 — COBE COP FILTER CARDIOPULMONARY PREBYPASS FILTERRapid Diagnostic Laboratories, Inc.·1985-04-10
• K842141 — SOLUTION CLARIFICATION UNITPall Biomedical Products Co.·1984-08-03
• K840450 — SHILEY PREBYPASS FILTERShiley, Inc.·1984-04-17
• K832594 — PRE-BYPASS FILTER #EC-PBF SERIESGish Biomedical, Inc.·1983-09-20
• K831286 — ULTIPORE PREBYPASS PLUS FILTERPall Biomedical Products Co.·1983-06-08
• K812539 — PRE-BYPASS FILTERGelman Sciences, Inc.·1981-10-13
• K812240 — INTERFACE PRE BYPASS PRIME FILTERMedical, Inc.·1981-08-25
• K812244 — INTERFACE PRE BYPASS PRIME FILTER #90Medical, Inc.·1981-08-25
• K810395 — PRE-BYPASS FILTERTexas Medical Products, Inc.·1981-03-05
• K803101 — PREBYPASS FILTER CAT.#K-5Delta Medical Industries·1980-12-22
• K800135 — CARDIOPLEGIA ADMINISTRATION SYSTEM CASBentley Laboratories, Inc.·1980-02-01
• K790361 — RECIRCULATION FILTER MODEL RF-10Bentley Laboratories, Inc.·1979-03-28
• K780485 — PREBYPASS FILTERDelta Medical Industries·1978-04-05