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FDA 510(k) Application Details - K213638
Device Classification Name
Introducer, Catheter
More FDA Info for this Device
510(K) Number
K213638
Device Name
Introducer, Catheter
Applicant
Argon Medical Devices
1445 Flat Creek Road
Athens, TX 75751 US
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Contact
Ana Jimenez-Hughes
Other 510(k) Applications for this Contact
Regulation Number
870.1340
More FDA Info for this Regulation Number
Classification Product Code
DYB
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More FDA Info for this Product Code
Date Received
11/18/2021
Decision Date
12/10/2021
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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