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FDA 510(k) Application Details - K182918
Device Classification Name
Catheter, Percutaneous
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510(K) Number
K182918
Device Name
Catheter, Percutaneous
Applicant
Balt USA LLC
29 Parker
Irvine, CA 92618 US
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Contact
Bilal Chamas
Other 510(k) Applications for this Contact
Regulation Number
870.1250
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Classification Product Code
DQY
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More FDA Info for this Product Code
Date Received
10/19/2018
Decision Date
03/21/2019
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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