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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheters, Transluminal Coronary Angioplasty, Percutaneous
510(k) Number K133852
Device Name APOLLO BALLOON DILATATION CATHETER
Applicant
Brosmed Medical
15th-Bldg.,Smes Venture Park,Songshan Lake Hi-Tech
Development Zone
Dongguan, Guangdong,  CN 523808
Applicant Contact STEPHEN LEE
Correspondent
Brosmed Medical
15th-Bldg.,Smes Venture Park,Songshan Lake Hi-Tech
Development Zone
Dongguan, Guangdong,  CN 523808
Correspondent Contact STEPHEN LEE
Regulation Number870.5100
Classification Product Code
LOX  
Date Received12/19/2013
Decision Date 09/19/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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