BAXTER ARENA HEMODIALYSIS DELIVERY SYSTEM, MODEL 1571278000


Device Classification Name

dialyzer, high permeability with or without sealed dialysate system

510(k) Number K030099
Device Name BAXTER ARENA HEMODIALYSIS DELIVERY SYSTEM, MODEL 1571278000
Original Applicant
BAXTER HEALTHCARE CORP.
1620 waukegan rd., mpr-a2e
mcgaw park, 
IL 
60085 -6730

Original Contact robert l wilkinson
Regulation Number 876.5860
Classification Product Code
KDI  
Date Received 01/10/2003
Decision Date 06/17/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

Gastroenterology/Urology

statement

statement

Type Traditional
Reviewed by Third Party Yes

Combination Product

No

Recalls CDRH Recalls