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510(k) K010264

Device
NIPRO BLOOD TUBING SET FOR HEMODIALYSIS WITH TRANSDUCER PROTECTORS AND PRIMING SET
Applicant
NIPRO MEDICAL CORP.
510(k) number
K010264
Product code
FIB  
Decision
Substantially Equivalent (SESE)
Decision date
2001-04-27
Date received
2001-01-29
Regulation
876.5820
Classification name
Protector, Transducer, Dialysis
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
RICHARD D BLISS, JR
Address
510 Stonemont Dr. Weston FL US 33326 33326

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code FIB  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K240164NovaLine SP-C35 Transducer Protector (956007)Bain Medical Equipment (Guangzhou) Co., Ltd.2024-06-28
K072988NIPRO TRANSDUCER PROTECTOR TP-SURE, MODEL TPSURE+1Nipro Medical Corporation2008-02-21
K001971HEMODIALYSIS TUBING SETSOfi Biomedica S.P.A.2001-05-24
K001465NIPRO BLOOD TUBING SET FOR HEMODIALYSIS WITH TRANSDUCER PROTECTORS AND PRIMING SETNipro Medical Corp.2000-12-05
K003445FRESENIUS VIRAL BLOCKING TRANSDUCER PROTECTOR FOR HEMODIALYSIS, MODEL 04-9500-2Fresenius Medical Care North America2000-12-01
K000702BORLA TRANSDUCER PROTECTOR & HAEMOTRONIC TRANSDUCER PROTECTORFresenius Medical Care North America2000-06-07
K983076MEDISYSTEMS TRANSDUCER PROTECTORMedisystems Corp.1998-11-25
K964337BETTER-BLADDER (BB)Circulatory Technology, Inc.1997-05-23
K970536MEDISYSTEMS TRANDUCER PROTECTORMedisystems Corp.1997-05-12
K934069MILLEX, DUALEX (PLUS, ULTRA)Millipore Corp.1994-04-21
K925978MPC-80 TRANSDUCERMolded Products, Inc.1994-01-14
K915593TRANSDUCER PROTECTORUnited Pharmaceutical and Medical Supply Co.1992-07-01
K912394TRANSDUCER PROTECTORFiltertek, Inc.1991-08-30
K910821TRANSDUCER PROTECTORGelman Sciences, Inc.1991-08-12
K911658DIALYSIS TRANDSDUCER PROTECTORTico Medical Instruments, Inc.1991-08-12

Legacy Summary#

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FDA Review#

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