OCCLUSION BALLOON CATHETER, MODEL VENOS


Device Classification Name

catheter, flow directed

510(k) Number K081052
Device Name OCCLUSION BALLOON CATHETER, MODEL VENOS
Applicant
Oscor Inc.
3816 de soto blvd.
palm harbor, 
FL 
34683

Applicant Contact mila doskocil
Correspondent
Oscor Inc.
3816 de soto blvd.
palm harbor, 
FL 
34683

Correspodent Contact mila doskocil
Regulation Number 870.1240
Classification Product Code
DYG  
Date Received 04/14/2008
Decision Date 06/18/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No