VASCUTRAK II PTA DILATATION CATHETER


Device Classification Name

catheter, angioplasty, peripheral, transluminal

510(k) Number K073025
Device Name VASCUTRAK II PTA DILATATION CATHETER
Applicant
THERMOPEUTIX INC. DBA YMED INC.
9925b business park ave.
san diego, 
CA 
92131

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

Correspodent Contact thomas schroeder
Regulation Number 870.1250
Classification Product Code
LIT  
Date Received 10/26/2007
Decision Date 11/09/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No