FDA 510(k) Applications for Medical Device Product Code "FIB"
(Protector, Transducer, Dialysis)

FDA 510(k) Number Applicant Device Name Decision Date
K964337 CIRCULATORY TECHNOLOGY, INC. BETTER-BLADDER (BB) 05/23/1997
K000702 FRESENIUS MEDICAL CARE NORTH AMERICA BORLA TRANSDUCER PROTECTOR & HAEMOTRONIC TRANSDUCER PROTECTOR 06/07/2000
K003445 FRESENIUS MEDICAL CARE NORTH AMERICA FRESENIUS VIRAL BLOCKING TRANSDUCER PROTECTOR FOR HEMODIALYSIS, MODEL 04-9500-2 12/01/2000
K970536 MEDISYSTEMS CORP. MEDISYSTEMS TRANDUCER PROTECTOR 05/12/1997
K983076 MEDISYSTEMS CORP. MEDISYSTEMS TRANSDUCER PROTECTOR 11/25/1998
K001465 NIPRO MEDICAL CORP. NIPRO BLOOD TUBING SET FOR HEMODIALYSIS WITH TRANSDUCER PROTECTORS AND PRIMING SET 12/05/2000
K010264 NIPRO MEDICAL CORP. NIPRO BLOOD TUBING SET FOR HEMODIALYSIS WITH TRANSDUCER PROTECTORS AND PRIMING SET 04/27/2001
K072988 NIPRO MEDICAL CORPORATION NIPRO TRANSDUCER PROTECTOR TP-SURE, MODEL TPSURE+1 02/21/2008
K001971 OFI BIOMEDICA S.P.A. HEMODIALYSIS TUBING SETS 05/24/2001


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