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FDA 510(k) Application Details - K951307
Device Classification Name
Wire, Guide, Catheter
More FDA Info for this Device
510(K) Number
K951307
Device Name
Wire, Guide, Catheter
Applicant
BAXTER HEALTHCARE CORP.
17221 RED HILL AVE.
PO BOX 11150
IRVINE, CA US
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Contact
PAULA A TORRIANNI
Other 510(k) Applications for this Contact
Regulation Number
870.1330
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Classification Product Code
DQX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/22/1995
Decision Date
06/22/1995
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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