THE CROSSER SYSTEM


Device Classification Name

catheter for crossing total occlusions

510(k) Number K072776
Device Name THE CROSSER SYSTEM
Applicant
FLOWCARDIA, INC.
745 n. pastoria ave.
sunnyvale, 
CA 
94085

Applicant Contact dustin michaels
Correspondent
FLOWCARDIA, INC.
745 n. pastoria ave.
sunnyvale, 
CA 
94085

Correspodent Contact dustin michaels
Regulation Number 870.1250
Classification Product Code
PDU  
Date Received 09/28/2007
Decision Date 12/07/2007
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