GISH ARTERIAL FILTER WITH GBS COATING


Device Classification Name

filter, blood, cardiopulmonary bypass, arterial line

510(k) Number K023833
Device Name GISH ARTERIAL FILTER WITH GBS COATING
Original Applicant
GISH BIOMEDICAL, INC.
11874 south evelyn circle
houston, 
TX 
77071

Original Contact j. harvey knauss
Regulation Number 870.4260
Classification Product Code
DTM  
Date Received 11/18/2002
Decision Date 03/31/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No