PRESEP OLIGON OXIMETRY CATHETERS (16 CM, W/HEPARIN), (20CM, W/HEPARIN)


Device Classification Name

catheter, oximeter, fiberoptic

510(k) Number K110167
Device Name PRESEP OLIGON OXIMETRY CATHETERS (16 CM, W/HEPARIN), (20CM, W/HEPARIN)
Applicant
EDWARDS LIFESCIENCES, LLC.
one edwards way
irvine, 
CA 
92614

Applicant Contact marguerite thomlinson
Correspondent
EDWARDS LIFESCIENCES, LLC.
one edwards way
irvine, 
CA 
92614

Correspodent Contact marguerite thomlinson
Regulation Number 870.1230
Classification Product Code
DQE  
Date Received 01/20/2011
Decision Date 02/18/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No