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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 K200744
Device Name Instylla Microcatheter
Applicant
Instylla, Inc.
204 2nd Avenue
Waltham,  MA  02451
Applicant Contact Jennifer Greer
Correspondent
Instylla, Inc.
204 2nd Avenue
Waltham,  MA  02451
Correspondent Contact Jennifer Greer
Regulation Number870.1210
Classification Product Code
KRA  
Date Received03/23/2020
Decision Date 04/21/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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