VISION HOLLOW FIBER OXYGENATOR WITH HA COATING


Device Classification Name

oxygenator, cardiopulmonary bypass

510(k) Number K080708
Device Name VISION HOLLOW FIBER OXYGENATOR 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 870.4350
Classification Product Code
DTZ  
Date Received 03/12/2008
Decision Date 02/02/2009
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No