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FDA 510(k) Application Details - K210009
Device Classification Name
Catheter, Percutaneous
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510(K) Number
K210009
Device Name
Catheter, Percutaneous
Applicant
CenterPoint Systems LLC
3338 Parkway Blvd
West Valley City, UT 84119 US
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Contact
Marybeth Gamber
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Regulation Number
870.1250
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Classification Product Code
DQY
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Date Received
01/04/2021
Decision Date
11/24/2021
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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