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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 K210808
Device Name Instylla Microcatheter 1.2
Applicant
Instylla, Inc.
201 Burlington Rd.
North Bldg.
Bedford,  MA  01730
Applicant Contact Jennifer Greer
Correspondent
Instylla, Inc.
201 Burlington Rd.
North Bldg.
Bedford,  MA  01730
Correspondent Contact Jennifer Greer
Regulation Number870.1210
Classification Product Code
KRA  
Date Received03/17/2021
Decision Date 04/15/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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