Atlas FDA

REPRIEVE ENDOVASCULAR TEMPERATURE THERAPY SYSTEM

FDA 510(k) clearance K071008 · decided 2007-05-09

Clearance details

K-number
K071008
Device name
REPRIEVE ENDOVASCULAR TEMPERATURE THERAPY SYSTEM
Applicant
Radiant Medical
Decision
Unknown
Date received
2007-04-09
Decision date
2007-05-09
Days to decision
30 days
Clearance type
Traditional
Product code
NCX
Device class
2
Regulation number
870.5900
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Redwood City, CA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.