CVSI PERIPHERAL BALLOON CATHETER; CVSI INFLATER


Device Classification Name

catheter, percutaneous

510(k) Number K022061
Device Name CVSI PERIPHERAL BALLOON CATHETER; CVSI INFLATER
Original Applicant
CRYO VASCULAR SYSTEMS INC.
160 knowles dr.
los gatos, 
CA 
95032

Original Contact r. michael crompton
Regulation Number 870.1250
Classification Product Code
DQY  
Subsequent Product Code
LIT  
Date Received 06/25/2002
Decision Date 09/20/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No