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FDA 510(k) Application Details - K093847
Device Classification Name
Catheter, Intravascular Occluding, Temporary
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510(K) Number
K093847
Device Name
Catheter, Intravascular Occluding, Temporary
Applicant
THERMOPEUTIX INC.
9925B BUSINESS PARK AVE.
SAN DIEGO, CA 92131 US
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THOMAS SCHROEDER
Other 510(k) Applications for this Contact
Regulation Number
870.4450
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Classification Product Code
MJN
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/16/2009
Decision Date
08/25/2010
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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