SOFT VENOUS RESERVOIR (SVRXX) WITH GBS COATING


Device Classification Name

reservoir, blood, cardiopulmonary bypass

510(k) Number K024065
Device Name SOFT VENOUS RESERVOIR (SVRXX) WITH GBS COATING
Original Applicant
GISH BIOMEDICAL, INC.
11874 south evelyn circle
houston, 
TX 
77071

Original Contact j harvey knauss
Regulation Number 870.4400
Classification Product Code
DTN  
Date Received 12/09/2002
Decision Date 03/05/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No