FDA 510(k) Application Details - K911089

Device Classification Name Catheter, Angioplasty, Peripheral, Transluminal

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510(K) Number K911089
Device Name Catheter, Angioplasty, Peripheral, Transluminal
Applicant TARGET THERAPEUTICS
130 RIO ROBLES
P.O. BOX 610458
SAN JOSE, CA US
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Contact CHARLES T MARONEY
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Regulation Number 870.1250

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Classification Product Code LIT
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Date Received 03/05/1991
Decision Date 05/29/1991
Decision SE - Substantially Equivalent
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status
Type Traditional
Reviewed By Third Party N
Expedited Review



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