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FDA 510(k) Application Details - K961847
Device Classification Name
Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
More FDA Info for this Device
510(K) Number
K961847
Device Name
Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
Applicant
MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP.
103 BAUER DR.
P.O. BOX 530
OAKLAND, NJ 07436 US
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Contact
CAROLYN TAUBER
Other 510(k) Applications for this Contact
Regulation Number
870.3450
More FDA Info for this Regulation Number
Classification Product Code
DSY
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/13/1996
Decision Date
01/22/1997
Decision
ST - Substantially Equivalent - Subject to Tracking Reg.
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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