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FIB — Protector, Transducer, Dialysis Class II

FDA Device Classification

Classification Details

Product Code
FIB
Device Class
Class II
Regulation Number
876.5820
Submission Type
Review Panel
GU
Medical Specialty
Gastroenterology, Urology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K240164bain medical equipment (guangzhou) coNovaLine SP-C35 Transducer Protector (956007)June 28, 2024
K072988nipro medical corporationNIPRO TRANSDUCER PROTECTOR TP-SURE, MODEL TPSURE+1February 21, 2008
K001971ofi biomedicaHEMODIALYSIS TUBING SETSMay 24, 2001
K010264nipro medicalNIPRO BLOOD TUBING SET FOR HEMODIALYSIS WITH TRANSDUCER PROTECTORS AND PRIMING SApril 27, 2001
K001465nipro medicalNIPRO BLOOD TUBING SET FOR HEMODIALYSIS WITH TRANSDUCER PROTECTORS AND PRIMING SDecember 5, 2000
K003445fresenius medical care north americaFRESENIUS VIRAL BLOCKING TRANSDUCER PROTECTOR FOR HEMODIALYSIS, MODEL 04-9500-2December 1, 2000
K000702fresenius medical care north americaBORLA TRANSDUCER PROTECTOR & HAEMOTRONIC TRANSDUCER PROTECTORJune 7, 2000
K983076medisystemsMEDISYSTEMS TRANSDUCER PROTECTORNovember 25, 1998
K964337circulatory technologyBETTER-BLADDER (BB)May 23, 1997
K970536medisystemsMEDISYSTEMS TRANDUCER PROTECTORMay 12, 1997
K934069milliporeMILLEX, DUALEX (PLUS, ULTRA)April 21, 1994
K925978molded productsMPC-80 TRANSDUCERJanuary 14, 1994
K915593united pharmaceutical and medical supplyTRANSDUCER PROTECTORJuly 1, 1992
K912394filtertekTRANSDUCER PROTECTORAugust 30, 1991
K911658tico medical instrumentsDIALYSIS TRANDSDUCER PROTECTORAugust 12, 1991
K910821gelman sciencesTRANSDUCER PROTECTORAugust 12, 1991
K904912filtertekTRANSDUCER PROTECTORJanuary 4, 1991
K902788arbo medicalCLEM TMSeptember 12, 1990
K901409filtertekTRANSDUCER PROTECTORJuly 27, 1990
K901996filtertekFILTERTEK PN 60650 DIALYSIS TRANSDUCER PROTECTORJune 1, 1990