Y-GLIDE


Device Classification Name

adaptor, stopcock, manifold, fitting, cardiopulmonary bypass

510(k) Number K072745
Device Name Y-GLIDE
Applicant
THOMAS MEDICAL PRODUCTS, INC.
65 great valley pkwy.
malvern, 
PA 
19355

Applicant Contact tim stoudt
Correspondent
THOMAS MEDICAL PRODUCTS, INC.
65 great valley pkwy.
malvern, 
PA 
19355

Correspodent Contact tim stoudt
Regulation Number 870.4290
Classification Product Code
DTL  
Date Received 09/27/2007
Decision Date 01/04/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls