APTUS 18FR HELIFX GUIDE-22 DEFLECTABLE LENGTH


Device Classification Name

endovascular suturing system

510(k) Number K121168
Device Name APTUS 18FR HELIFX GUIDE-22 DEFLECTABLE LENGTH
Applicant
APTUS ENDOSYSTEMS, INC.
777 n. pastoria ave.
sunnyvale, 
CA 
94085

Applicant Contact burt goodson
Correspondent
APTUS ENDOSYSTEMS, INC.
777 n. pastoria ave.
sunnyvale, 
CA 
94085

Correspodent Contact burt goodson
Regulation Number 870.3460
Classification Product Code
OTD  
Date Received 04/17/2012
Decision Date 08/08/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No