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FDA 510(k) Application Details - K180694
Device Classification Name
Catheter, Peripheral, Atherectomy
More FDA Info for this Device
510(K) Number
K180694
Device Name
Catheter, Peripheral, Atherectomy
Applicant
Spectranetics, Inc.
9965 Federal Drive
Colorado Springs, CO 80921 US
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Contact
Travis Pittman
Other 510(k) Applications for this Contact
Regulation Number
870.4875
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Classification Product Code
MCW
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More FDA Info for this Product Code
Date Received
03/16/2018
Decision Date
04/05/2018
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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