TECHDEVICE OCCLUSION BALLOON CATHETER


Device Classification Name

catheter, intravascular occluding, temporary

510(k) Number K051137
Device Name TECHDEVICE OCCLUSION BALLOON CATHETER
Applicant
TECHDEVICE CORPORATION
650 pleasant st.
watertown, 
MA 
02472

Applicant Contact leigh hayward
Correspondent
TECHDEVICE CORPORATION
650 pleasant st.
watertown, 
MA 
02472

Correspodent Contact leigh hayward
Regulation Number 870.4450
Classification Product Code
MJN  
Date Received 05/04/2005
Decision Date 02/24/2006
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls