Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K113638
Device Classification Name
Catheter, Intravascular, Diagnostic
More FDA Info for this Device
510(K) Number
K113638
Device Name
Catheter, Intravascular, Diagnostic
Applicant
NAVILYST MEDICAL, INC.
26 FOREST STREET
MARLBOROUGH, MA 01752 US
Other 510(k) Applications for this Company
Contact
WANDA CARPINELLA
Other 510(k) Applications for this Contact
Regulation Number
870.1200
More FDA Info for this Regulation Number
Classification Product Code
DQO
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/09/2011
Decision Date
01/05/2012
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact