CHARTER GUIDEWIRE MODEL 45-281, 45-282, 45-283


Device Classification Name

wire, guide, catheter

510(k) Number K103377
Device Name CHARTER GUIDEWIRE MODEL 45-281, 45-282, 45-283
Applicant
BRIVANT, LTD.
parkmore west business park
galway, 

IE

ei

Applicant Contact tomas furey
Correspondent
BRIVANT, LTD.
parkmore west business park
galway, 

IE

ei

Correspodent Contact tomas furey
Regulation Number 870.1330
Classification Product Code
DQX  
Date Received 11/17/2010
Decision Date 05/18/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No