VISION HOLLOW FIBER OXYGENATOR WITH GUARDIAN COATING


Device Classification Name

oxygenator, cardiopulmonary bypass

510(k) Number K023381
Device Name VISION HOLLOW FIBER OXYGENATOR WITH GUARDIAN COATING
Original Applicant
GISH BIOMEDICAL, INC.
11874 south evelyn circle
houston, 
TX 
77071

Original Contact j. harvey knauss
Regulation Number 870.4350
Classification Product Code
DTZ  
Date Received 10/08/2002
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

Recalls CDRH Recalls