GISH ARTERIAL FILTER WITH HA COATING


Device Classification Name

filter, blood, cardiopulmonary bypass, arterial line

510(k) Number K081054
Device Name GISH ARTERIAL FILTER WITH HA COATING
Applicant
GISH BIOMEDICAL, INC.
11874 south evelyn circle
houston, 
TX 
77071

Applicant Contact harvey knauss
Correspondent
GISH BIOMEDICAL, INC.
11874 south evelyn circle
houston, 
TX 
77071

Correspodent Contact harvey knauss
Regulation Number 870.4260
Classification Product Code
DTM  
Date Received 04/14/2008
Decision Date 01/15/2009
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No