FDA 510(k) Application Details - K090665

Device Classification Name Temporary Carotid Catheter For Embolic Capture

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510(K) Number K090665
Device Name Temporary Carotid Catheter For Embolic Capture
Applicant ABBOTT VASCULAR-VASCULAR SOLUTIONS
3200 LAKESIDE DR.
SANTA CLARA, CA 95054 US
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Contact DANIELLE TAYLOR
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Regulation Number 870.1250

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Classification Product Code NTE
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Date Received 03/13/2009
Decision Date 05/22/2009
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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