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510(k) K810114

Device
VASCULAR ACCESS SYSTEM
Applicant
BENTLEY LABORATORIES, INC.
510(k) number
K810114
Product code
FIQ  
Decision
Substantially Equivalent (SESE)
Decision date
1981-03-26
Date received
1980-12-15
Regulation
876.5540
Classification name
Cannula, A-v Shunt
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code FIQ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K892887ST SERIES SAF-T-SHUNTS ARTERIOVENOUS CANNULAAkcess Medical Products, Inc.1989-05-15
K892666SAF-T-SHUNT, S-300 SERIESAkcess Medical Products, Inc.1989-05-04
K892663S-100 ALLEN-BROWN SHUNTAkcess Medical Products, Inc.1989-05-04
K844692PEDIATRIC SIZED HEMOCATH CATHETERQuinton, Inc.1985-01-18
K841791PLUME FISTULA NEEDLEHospal Medical Corp.1984-07-09
K840322HEMOFILTRATION CATHETER HF-100Vas-Cath of Canada , Ltd.1984-04-24
K840415HEMOCATHQuinton, Inc.1984-04-20
K834358PARALLEL DUAL LUMEN SUBCLAVIAN CANNULAVas-Cath of Canada , Ltd.1984-04-02
K840436HEMASITE/RENALOY -VASCULAR ACCESS SHUNTRenal Systems, Inc.1984-02-21
K833622RENALLOY HEMASITE VASCULAR ACCESS SHUNTRenal Systems, Inc.1983-11-29
K831801HEMOCLAV VENOUS CATHETERExo, Inc.1983-07-07
K831440SINGLE NEEDLE SUBCLAVIAN VEIN MWI250/260Med-West, Inc.1983-06-03
K831401SINGLE NEEDLE SUBCLAVIAN VEIN ACCESSMed-West, Inc.1983-06-03
K823752EXTRACORPOREAL SUBCLAVIAN CATHETER KITExtracorporeal Medical Specialities, Inc.1983-01-14
K822880ARTERIO VENOUS SHUNT CANNULA & ADAPTORSRenal Systems, Inc.1982-10-18

Legacy Summary#

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FDA Review#

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