FDA 510(k) Application Details - K915168

Device Classification Name Catheter, Angioplasty, Peripheral, Transluminal

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510(K) Number K915168
Device Name Catheter, Angioplasty, Peripheral, Transluminal
Applicant PERIPHERAL SYSTEMS GROUP
1395 CHARLESTON RD.
MOUNTAIN VIEW, CA US
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Contact LINDA GUTHRIE
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Regulation Number 870.1250

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Classification Product Code LIT
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Date Received 11/15/1991
Decision Date 02/19/1992
Decision SE - Substantially Equivalent
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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