CVSI PERIPHERAL BALLOON CATHETER; CVSI CATHETER INFLATION UNIT


Device Classification Name

catheter, percutaneous

510(k) Number K023463
Device Name CVSI PERIPHERAL BALLOON CATHETER; CVSI CATHETER INFLATION UNIT
Original Applicant
CRYOVASCULAR 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 10/15/2002
Decision Date 02/19/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No