FDA 510(k) Application Details - K972944

Device Classification Name Wire, Guide, Catheter

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510(K) Number K972944
Device Name Wire, Guide, Catheter
Applicant MEDTRONICS INTERVENTIONAL VASCULAR
9410 CARROLL PARK DR.
SAN DIEGO, CA 92121-2256 US
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Contact MARY DE ARMOND
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Regulation Number 870.1330

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Classification Product Code DQX
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Date Received 08/11/1997
Decision Date 11/03/1997
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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