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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Angioplasty, Peripheral, Transluminal
510(k) Number K201246
Device Name PTA Balloon Catheter (PVQ), MIT PTA Balloon Catheter (PVQ)
Applicant
Qualimed USA, LLC
1800 Camden Rd., Suite 107 (P.O Box 252)
Charlotte,  NC  28203
Applicant Contact Manfred Gulcher
Correspondent
Alston & Bird, Llp
950 F St. NW
Washington,  DC  20004
Correspondent Contact Marc J. Scheineson
Regulation Number870.1250
Classification Product Code
LIT  
Date Received05/08/2020
Decision Date 08/03/2021
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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