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510(k) K910502

Device
VESSEL DILATORS
Applicant
AKCESS MEDICAL PRODUCTS, INC.
510(k) number
K910502
Product code
FKA  
Decision
Substantially Equivalent (SESE)
Decision date
1991-04-29
Date received
1991-02-05
Regulation
876.5540
Classification name
Dilator, Vessel
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
BALBIR B KAPANY
Address
789 Jersey Ave. New Brunswick NJ US 08901 08901

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code FKA  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K022620SHEATHLESS ACCESSORY KIT, MODELS XRIK24, XRIK28, XRIK32, XRIK36, XRIK40 AND XRIKRTSpire Biomedical, Inc.2002-10-11
K914210VAS-CATH DUALATOR(TM) VESSEL DILATORVas-Cath, Inc.1993-07-01

Legacy Summary#

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FDA Review#

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