EMBOL-X INTRODUCER, MODEL CF00200


Device Classification Name

introducer, catheter

510(k) Number K002973
Device Name EMBOL-X INTRODUCER, MODEL CF00200
Original Applicant
EMBOL-X, INC.
645 clyde ave.
mountain view, 
CA 
94043

Original Contact ed lee
Regulation Number 870.1340
Classification Product Code
DYB  
Date Received 09/22/2000
Decision Date 04/26/2001
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

Type Traditional
Reviewed by Third Party No

Combination Product

No