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FDA 510(k) Application Details - K950156
Device Classification Name
Wire, Guide, Catheter
More FDA Info for this Device
510(K) Number
K950156
Device Name
Wire, Guide, Catheter
Applicant
ADVANCED CARDIOVASCULAR SYSTEMS, INC.
3200 LAKESIDE DR.
P.O. BOX 58167
SANTA CLARA, CA US
Other 510(k) Applications for this Company
Contact
J P PALIN
Other 510(k) Applications for this Contact
Regulation Number
870.1330
More FDA Info for this Regulation Number
Classification Product Code
DQX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/17/1995
Decision Date
04/05/1995
Decision
SE - Substantially Equivalent
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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