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FDA 510(k) Application Details - K223530
Device Classification Name
Catheter, Thrombus Retriever
More FDA Info for this Device
510(K) Number
K223530
Device Name
Catheter, Thrombus Retriever
Applicant
Route 92 Medical, Inc.
155 Bovet Road, Suite 100
San Mateo, CA 94402 US
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Contact
Kirsten Valley
Other 510(k) Applications for this Contact
Regulation Number
870.1250
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Classification Product Code
NRY
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More FDA Info for this Product Code
Date Received
11/23/2022
Decision Date
04/11/2023
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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