PALMAZ GENESIS TRANSHEPATIC BILLARY STENT AND DELIVERY SYSTEM


Device Classification Name

catheter, biliary, diagnostic

510(k) Number K010411
Device Name PALMAZ GENESIS TRANSHEPATIC BILLARY STENT AND DELIVERY SYSTEM
Original Applicant
CORDIS CORP.
7 powder horn dr.
warren, 
NJ 
07059

Original Contact charles j ryan
Regulation Number 876.5010
Classification Product Code
FGE  
Date Received 02/12/2001
Decision Date 08/27/2001
Decision

se – with limitations

(SESU)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

Gastroenterology/Urology

Type Abbreviated
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls