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FDA 510(k) Application Details - K172790
Device Classification Name
Catheter, Intravascular Occluding, Temporary
More FDA Info for this Device
510(K) Number
K172790
Device Name
Catheter, Intravascular Occluding, Temporary
Applicant
Prytime Medical Devices, Inc.
229 North Main Street
Boerne, TX 78006 US
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Contact
Brian Young
Other 510(k) Applications for this Contact
Regulation Number
870.4450
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Classification Product Code
MJN
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/15/2017
Decision Date
11/08/2017
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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