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FDA 510(k) Application Details - K221541
Device Classification Name
More FDA Info for this Device
510(K) Number
K221541
Device Name
LimFlow ARC
Applicant
LimFlow, Inc.
3031 Tisch Way - 110 Plaza West
San Jose, CA 95128 US
Other 510(k) Applications for this Company
Contact
Zachary Woodson
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
PDU
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/27/2022
Decision Date
08/31/2022
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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