COOK VASCULAR SERPENTA CORONARY SINUS INTRODUCER SYSTEM


Device Classification Name

introducer, catheter

510(k) Number K023937
Device Name COOK VASCULAR SERPENTA CORONARY SINUS INTRODUCER SYSTEM
Original Applicant
COOK VASCULAR, INC.
rt. 66, river rd.
p.o. box 529
leechburg, 
PA 
15656 -0529

Original Contact thomas j kardos
Regulation Number 870.1340
Classification Product Code
DYB  
Date Received 11/26/2002
Decision Date 05/27/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No