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FDA 510(k) Application Details - K221930
Device Classification Name
More FDA Info for this Device
510(K) Number
K221930
Device Name
CEREGLIDE 71 Intermediate Catheter
Applicant
Cerenovus, Inc.
6303 Blue Lagoon Drive, Suite 215 & 315
Miami, FL 33126 US
Other 510(k) Applications for this Company
Contact
Ariell Joner
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
QJP
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/01/2022
Decision Date
03/09/2023
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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