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FDA 510(k) Application Details - K190431
Device Classification Name
Catheter, Percutaneous
More FDA Info for this Device
510(K) Number
K190431
Device Name
Catheter, Percutaneous
Applicant
Route 92 Medical Inc.
1700 S. El Camino Real, Suite 206
San Mateo, CA 94402 US
Other 510(k) Applications for this Company
Contact
Kathy Tansey
Other 510(k) Applications for this Contact
Regulation Number
870.1250
More FDA Info for this Regulation Number
Classification Product Code
DQY
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/22/2019
Decision Date
03/21/2019
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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