Atlas FDA

INNERCOOL THERAPIES, INC., RAPIDBLUE SYSTEM

FDA 510(k) clearance K080908 · decided 2008-10-17

Clearance details

K-number
K080908
Device name
INNERCOOL THERAPIES, INC., RAPIDBLUE SYSTEM
Applicant
Innercool Therapies, Inc.- A Delaware Corporation
Decision
Substantially Equivalent
Date received
2008-04-01
Decision date
2008-10-17
Days to decision
199 days
Clearance type
Special
Product code
NCX
Device class
2
Regulation number
870.5900
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
San Diego, CA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
InnerCool RTx Endovascular System, Model Numbers: 861470 (120V), 861472 (240V). Product Us recall (Z-0845-2014)Philips Healthcare2014-01-27