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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Percutaneous
510(k) Number K123311
Device Name QXMEDICAL ACCESS & SUPPORT CATHETER
Applicant
Qxmedical, LLC
1843 Buerkle Rd.
White Bear Lake,  MN  55110
Applicant Contact FERNANDO DI CAPRIO
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Regulation Number870.1250
Classification Product Code
DQY  
Date Received10/25/2012
Decision Date 01/14/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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