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FDA 510(k) Application Details - K211738
Device Classification Name
Catheter, Peripheral, Atherectomy
More FDA Info for this Device
510(K) Number
K211738
Device Name
Catheter, Peripheral, Atherectomy
Applicant
C.R. Bard, Inc.
1625 West 3rd St
Tempe, AZ 85281 US
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Contact
Aaron Conovaloff
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
06/07/2021
Decision Date
09/14/2021
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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