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FDA 510(k) Application Details - K230374
Device Classification Name
Catheters, Transluminal Coronary Angioplasty, Percutaneous
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510(K) Number
K230374
Device Name
Catheters, Transluminal Coronary Angioplasty, Percutaneous
Applicant
Dongguan TT Medical, Inc
Bld #1, Rm 501, 502,1 Taoyuan Rd
Songshan Lake,Guangdong
Dongguan 523808 CN
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Contact
Yuying Bi
Other 510(k) Applications for this Contact
Regulation Number
000.0000
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Classification Product Code
LOX
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More FDA Info for this Product Code
Date Received
02/13/2023
Decision Date
06/29/2023
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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