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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Continuous Flush
510(k) Number K161967
Device Name FluidiTube 2.7F Infusion Micro Catheter, 110 cm and 130 cm
Applicant
Callisyn Biomedical, Inc.
260 Candlestick Rd.
North Andover,  MA  01845
Applicant Contact Shallwei Sun
Correspondent
Icon
62 Forest St., Suite 300
Marlborough,  MA  01752
Correspondent Contact Gordon MacFarlane
Regulation Number870.1210
Classification Product Code
KRA  
Date Received07/18/2016
Decision Date 01/27/2017
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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