FDA 510(k) Application Details - K961333

Device Classification Name Clip, Vascular

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510(K) Number K961333
Device Name Clip, Vascular
Applicant HEARTPORT, INC.
200 CHESAPEAKE DR.
REDWOOD CITY, CA 94063 US
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Contact ISABELLA R ABATI
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Regulation Number 870.3250

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Classification Product Code DSS
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Date Received 04/08/1996
Decision Date 11/15/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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