NAVIS TORQUER


Device Classification Name

wire, guide, catheter

510(k) Number K112674
Device Name NAVIS TORQUER
Applicant
NAVIS MEDICAL,INC
5705 whispering trl
galena, 
OH 
43021

Applicant Contact matthew j huddleston
Correspondent
NAVIS MEDICAL,INC
5705 whispering trl
galena, 
OH 
43021

Correspodent Contact matthew j huddleston
Regulation Number 870.1330
Classification Product Code
DQX  
Date Received 09/14/2011
Decision Date 07/06/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No