FDA 510(k) Application Details - K993648

Device Classification Name Catheter, Peripheral, Atherectomy

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510(K) Number K993648
Device Name Catheter, Peripheral, Atherectomy
Applicant BOSTON SCIENTIFIC CORPORATION NORTHWEST TECHNOLOGY
17425 N.E. UNION HILL RD.
REDMOND, WA 98052 US
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Contact CYNDY ADAMS
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Regulation Number 870.4875

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Classification Product Code MCW
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Date Received 10/29/1999
Decision Date 11/24/1999
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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