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FDA 510(k) Application Details - K213854
Device Classification Name
Wire, Guide, Catheter
More FDA Info for this Device
510(K) Number
K213854
Device Name
Wire, Guide, Catheter
Applicant
Opsens Inc.
750 Boulevard du Parc Technologique
QuΘbec G1P 4S3 CA
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Contact
Marc Chaunet
Other 510(k) Applications for this Contact
Regulation Number
870.1330
More FDA Info for this Regulation Number
Classification Product Code
DQX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/10/2021
Decision Date
09/14/2022
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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