DUOFLO CATHETER


Device Classification Name

catheter, intravascular occluding, temporary

510(k) Number K080700
Device Name DUOFLO CATHETER
Applicant
THERMOPEUTIX INC.
9925b business park ave.
san diego, 
CA 
92131

Regulation Number 870.4450
Classification Product Code
MJN  
Date Received 03/11/2008
Decision Date 09/26/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No