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FDA 510(k) Application Details - K190037
Device Classification Name
Catheter, Angioplasty, Peripheral, Transluminal
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510(K) Number
K190037
Device Name
Catheter, Angioplasty, Peripheral, Transluminal
Applicant
Nipro Medical Corporation
3150 NW 107th Ave.
Doral, FL 33172 US
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Contact
Jessica Oswald-McLeon
Other 510(k) Applications for this Contact
Regulation Number
870.1250
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Classification Product Code
LIT
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More FDA Info for this Product Code
Date Received
01/08/2019
Decision Date
10/24/2019
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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