XPRESSWAY RX CATHETER (6F LD-VERISON)


Device Classification Name

catheter, embolectomy

510(k) Number K121301
Device Name XPRESSWAY RX CATHETER (6F LD-VERISON)
Applicant
KANEKA PHARMA AMERICA LLC
546 fifth ave., 21st floor
new york, 
NY 
10036

Applicant Contact joseph depaolo
Correspondent
KANEKA PHARMA AMERICA LLC
546 fifth ave., 21st floor
new york, 
NY 
10036

Correspodent Contact joseph depaolo
Regulation Number 870.5150
Classification Product Code
DXE  
Date Received 05/01/2012
Decision Date 07/30/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

statement

statement

Type Special
Reviewed by Third Party No

Combination Product

No