FDA 510(k) Application Details - K013635

Device Classification Name

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510(K) Number K013635
Device Name TRELLIS INFUSION SYSTEM (10CM INFUSION LENGTH); TRELLIS INFUSION SYSTEM (20CM INFUSION LENGTH)
Applicant BACCHUS VASCULAR, INC.
3110 CORONADO DR.
SANTA CLARA, CA 95054 US
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Contact GREG MATHISON
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Regulation Number

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Classification Product Code QEY
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Date Received 11/05/2001
Decision Date 02/11/2002
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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