EMBOL-X AORTIC FILTERS,ETRA-SMALL,SMALL,MEDIUM,LARGE,EXTRA LARGE,MODELS CF26000.CF29000,CF32000,CF35000,CF4000


Device Classification Name

filter, blood, cardiopulmonary bypass, arterial line

510(k) Number K022071
Device Name EMBOL-X AORTIC FILTERS,ETRA-SMALL,SMALL,MEDIUM,LARGE,EXTRA LARGE,MODELS CF26000.CF29000,CF32000,CF35000,CF4000
Original Applicant
EMBOL-X, INC.
645 clyde ave.
mountain view, 
CA 
94043

Original Contact ed lee
Regulation Number 870.4260
Classification Product Code
DTM  
Date Received 06/26/2002
Decision Date 02/14/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls