Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K230705
Device Classification Name
Catheters, Transluminal Coronary Angioplasty, Percutaneous
More FDA Info for this Device
510(K) Number
K230705
Device Name
Catheters, Transluminal Coronary Angioplasty, Percutaneous
Applicant
BrosMed Medical Co., Ltd.
15th Building, SMEs Venture Park, SongShan Lake
Hi-Tech Industrial Development Zone
Dongguan 523808 CN
Other 510(k) Applications for this Company
Contact
Crystal Lee
Other 510(k) Applications for this Contact
Regulation Number
000.0000
More FDA Info for this Regulation Number
Classification Product Code
LOX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/14/2023
Decision Date
04/11/2023
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
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact