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FDA 510(k) Application Details - K210635
Device Classification Name
More FDA Info for this Device
510(K) Number
K210635
Device Name
Route 92 Medical Full Length 088 Access System
Applicant
Route 92 Medical Inc.
155 Bovet Road, Suite 100
San Mateo, CA 94402 US
Other 510(k) Applications for this Company
Contact
Kirsten Valley
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
03/03/2021
Decision Date
07/27/2021
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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