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FDA 510(k) Application Details - K171610
Device Classification Name
More FDA Info for this Device
510(K) Number
K171610
Device Name
MC3 QuickFlow Dual Lumen Catheter
Applicant
MC3 Incorporated
2555 Bishop Circle West
Dexter, MI 48130 US
Other 510(k) Applications for this Company
Contact
Martha Rumford
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
PZS
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/01/2017
Decision Date
11/16/2017
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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