FDA.reportPublic FDA data

510(k) K001971

Device
HEMODIALYSIS TUBING SETS
Applicant
Ofi Biomedica S.P.A.
510(k) number
K001971
Product code
FIB
Decision
Substantially Equivalent (SESE)
Decision date
2001-05-24
Date received
2000-06-28
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
N

Applicant Contact#

Contact
MARY MCNAMARA-CULLINANE
Address
49 Plain St. North Attleboro MA US 02760 02760

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
K010264NIPRO BLOOD TUBING SET FOR HEMODIALYSIS WITH TRANSDUCER PROTECTORS AND PRIMING SETNipro Medical Corp.2001-04-27
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