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FDA 510(k) Application Details - K001917
Device Classification Name
Catheter, Intravascular Occluding, Temporary
More FDA Info for this Device
510(K) Number
K001917
Device Name
Catheter, Intravascular Occluding, Temporary
Applicant
ARTERIA MEDICAL SCIENCE, INC.
P.O. BOX 3515
REDMOND, WA 98073-3515 US
Other 510(k) Applications for this Company
Contact
STEVE CHERNOFF
Other 510(k) Applications for this Contact
Regulation Number
870.4450
More FDA Info for this Regulation Number
Classification Product Code
MJN
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/23/2000
Decision Date
06/06/2001
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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