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510(k) K914210

Device
VAS-CATH DUALATOR(TM) VESSEL DILATOR
Applicant
VAS-CATH, INC.
510(k) number
K914210
Product code
FKA  
Decision
Substantially Equivalent (SESE)
Decision date
1993-07-01
Date received
1991-09-19
Regulation
876.5540
Classification name
Dilator, Vessel
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
MARCO A GUILLEN
Address
2380 Tedlo St. Mississauga, Ontario CA L5A 3V3 L5A 3V3

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
K910502VESSEL DILATORSAkcess Medical Products, Inc.1991-04-29

Legacy Summary#

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FDA Review#

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