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FDA 510(k) Application Details - K972142
Device Classification Name
Wire, Guide, Catheter
More FDA Info for this Device
510(K) Number
K972142
Device Name
Wire, Guide, Catheter
Applicant
GUIDANT CORP.
26531 YNEZ RD.
PO BOX 9810
TEMECULA, CA 92591-4628 US
Other 510(k) Applications for this Company
Contact
WAYNE R HOHMAN
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
06/06/1997
Decision Date
08/25/1997
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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