SETPOINT ENDOVASCULAR TEMPERATURE PROBE


Device Classification Name

catheter, percutaneous

510(k) Number K024327
Device Name SETPOINT ENDOVASCULAR TEMPERATURE PROBE
Original Applicant
RADIANT MEDICAL
250 chesapeake dr.
redwood city, 
CA 
94063

Original Contact andrew cleeland
Regulation Number 870.1250
Classification Product Code
DQY  
Date Received 12/26/2002
Decision Date 03/25/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No