FDA 510(k) Application Details - K022640

Device Classification Name Catheter, Peripheral, Atherectomy

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510(K) Number K022640
Device Name Catheter, Peripheral, Atherectomy
Applicant BACCHUS VASCULAR, INC.
3110 CORONADO DR.
SANTA CLARA, CA 95054 US
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Contact GREGORY J MATHISON
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Regulation Number 870.4875

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Classification Product Code MCW
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Date Received 08/08/2002
Decision Date 12/02/2002
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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