REFLEXION HD HIGH-DENSITY MAPPING CATHETER


Device Classification Name

catheter, electrode recording, or probe, electrode recording

510(k) Number K080179
Device Name REFLEXION HD HIGH-DENSITY MAPPING CATHETER
Applicant
ST. JUDE MEDICAL
14901 deveau pl.
minnetonka, 
MN 
55345 -2126

Applicant Contact andrea hudack
Correspondent
ST. JUDE MEDICAL
14901 deveau pl.
minnetonka, 
MN 
55345 -2126

Correspodent Contact andrea hudack
Regulation Number 870.1220
Classification Product Code
DRF  
Date Received 01/24/2008
Decision Date 01/07/2009
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No