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FDA 510(k) Application Details - K191664
Device Classification Name
Catheter, Percutaneous
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510(K) Number
K191664
Device Name
Catheter, Percutaneous
Applicant
Q'Apel Medical
330 Wilshire Boulevard
Santa Monica, CA 90401 US
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Contact
Ken Peartree
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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
06/21/2019
Decision Date
08/30/2019
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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