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FDA 510(k) Application Details - K220808
Device Classification Name
Catheter, Thrombus Retriever
More FDA Info for this Device
510(K) Number
K220808
Device Name
Catheter, Thrombus Retriever
Applicant
Rapid Medical Ltd.
Carmel Building, POB 337
Yokneam 2069205 IL
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Contact
Orit Yaniv
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
03/18/2022
Decision Date
07/25/2022
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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