FDA 510(k) Application Details - K101648

Device Classification Name Wire, Guide, Catheter

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510(K) Number K101648
Device Name Wire, Guide, Catheter
Applicant ABBOTT VASCULAR INC.
3200 Lakeside Drive
Santa Clara, CA 95054 US
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Contact LAARNI RICAFORT
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Regulation Number 870.1330

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Classification Product Code DQX
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Date Received 06/11/2010
Decision Date 07/08/2010
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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