GUIDANT BALLOON CATHETER, SEVERAL MODELS


Device Classification Name

catheter, intravascular, diagnostic

510(k) Number K021283
Device Name GUIDANT BALLOON CATHETER, SEVERAL MODELS
Original Applicant
GUIDANT CORP.
4100 hamline ave., north
st. paul, 
MN 
55112 -5798

Original Contact karen s alsop
Regulation Number 870.1200
Classification Product Code
DQO  
Date Received 04/18/2002
Decision Date 05/02/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No