ENDOLOGIX GUIDEWIRE


Device Classification Name

wire, guide, catheter

510(k) Number K110241
Device Name ENDOLOGIX GUIDEWIRE
Applicant
TECHDEVICE CORPORATION
650 pleasant st.
watertown, 
MA 
02472

Applicant Contact gary bunnewith
Correspondent
TECHDEVICE CORPORATION
650 pleasant st.
watertown, 
MA 
02472

Correspodent Contact gary bunnewith
Regulation Number 870.1330
Classification Product Code
DQX  
Date Received 01/27/2011
Decision Date 02/25/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No