SMITHWICK CAROTID SHUNT


Device Classification Name

clamp, vascular

510(k) Number K021608
Device Name SMITHWICK CAROTID SHUNT
Original Applicant
IMPLANTABLE DEVICES
p.o. box 270882
tampa, 
FL 
33688

Original Contact william e mcpherson
Regulation Number 870.4450
Classification Product Code
DXC  
Date Received 05/16/2002
Decision Date 10/22/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No