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FDA 510(k) Application Details - K193380
Device Classification Name
Catheter, Thrombus Retriever
More FDA Info for this Device
510(K) Number
K193380
Device Name
Catheter, Thrombus Retriever
Applicant
Codman & Shurtleff, Inc.
325 Paramount Drive
Raynham, MA 02767 US
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Contact
Kirsten Franco
Other 510(k) Applications for this Contact
Regulation Number
870.1250
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Classification Product Code
NRY
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/05/2019
Decision Date
07/20/2020
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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