TAPAS CATHETER


Device Classification Name

catheter, intravascular occluding, temporary

510(k) Number K112219
Device Name TAPAS CATHETER
Applicant
THERMOPEUTIX INC.
9925b business park ave.
san diego, 
CA 
92131

Applicant Contact thomas schroeder
Correspondent
THERMOPEUTIX INC.
9925b business park ave.
san diego, 
CA 
92131

Correspodent Contact thomas schroeder
Regulation Number 870.4450
Classification Product Code
MJN  
Date Received 08/02/2011
Decision Date 11/18/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No