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FDA 510(k) Application Details - K180194
Device Classification Name
System&Accessories,Isolated Heart,Transport&Preservation
More FDA Info for this Device
510(K) Number
K180194
Device Name
System&Accessories,Isolated Heart,Transport&Preservation
Applicant
Paragonix Technologies, Inc.
d/o Vaughn & Asociates
639 Granite Street
Braintree, MA 021184 US
Other 510(k) Applications for this Company
Contact
Leo Basta
Other 510(k) Applications for this Contact
Regulation Number
876.5880
More FDA Info for this Regulation Number
Classification Product Code
MSB
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/24/2018
Decision Date
03/30/2018
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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