CROSSER LP SYSTEM


Device Classification Name

wire, guide, catheter

510(k) Number K080765
Device Name CROSSER LP 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 870.1330
Classification Product Code
DQX  
Date Received 03/18/2008
Decision Date 06/20/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No