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510(k) K830674

Device
Mahurkar Femoral Catheter
Applicant
QUINTON, INC.
510(k) number
K830674
Product code
LFK
Decision
Substantially Equivalent (SESE)
Decision date
1983-05-18
Date received
1983-03-04
Regulation
876.5540
Classification name
Catheter, Femoral
Medical specialty
Gastroenterology, Urology
Review panel
Gastroenterology, Urology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
RANDY WALLS
Address
3303 Monte Villa Pkwy. Bothell WA US 98021 98021

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code LFK#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K971897CONTINUOUS ARTERIOVENOUS HEMOFILTRATION CATHETER 10 FR (CAVH)Medron, Inc.1997-10-21
K914936CONTINUOUS ARTERIOVENOUS HEMOFILTRATION CATH SETAkcess Medical Products, Inc.1992-04-23
K915215CONTINUOUS ARTERIOVENOUS HEMOFILTRATION CATH. KITSAkcess Medical Products, Inc.1992-03-27
K891763FC-100 FEMORAL CATHETERAkcess Medical Products, Inc.1989-04-07
K891764FC-101 FEMORAL CATHETER GUIDE WIREAkcess Medical Products, Inc.1989-04-07
K890717MODIFICATION HEMOFILTRATION CATHETER HF-100Vas-Cath, Inc.1989-04-05
K880775CONTINUOUS ARTERIAL/VENOUS HEMOFILTRATION TRAYMedsurg Industries, Inc.1988-07-25
K882466VAS-CATH PEDIATRIC HEMOFILTRATION CATHETERVas-Cath, Inc.1988-07-13
K865096NEW SECOND FRENCH SIZE MAHURKAR CATHETERQuinton, Inc.1987-02-18
K863218CYTOSTATIC FILTRATION SETMeadox Surgimed, Inc.1987-02-12
K862771MEDCOMP C.A.V.H. CATHETERMedical Components, Inc.1986-08-06
K860810MEDCOMP'S FEMORAL VEIN CATHETERSMedical Components, Inc.1986-04-08
K854612ACUTE HEMODIALYSIS TRAY, CAT.#09-9540-7Med-West, Inc.1986-01-03
K831828TEFLON FEMORAL CATHETER MWI 100,10 &Med-West, Inc.1983-07-07
K820237COBE ACUFLEX FSN, #15-208Cobe Laboratories, Inc.1982-03-10