Cleared Special

Instylla Microcatheter

K200744 · Instylla, Inc. · Cardiovascular
Apr 2020
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K200744 is an FDA 510(k) clearance for the Instylla Microcatheter, a Catheter, Continuous Flush (Class II — Special Controls, product code KRA), submitted by Instylla, Inc. (Waltham, US). The FDA issued a Cleared decision on April 21, 2020, 29 days after receiving the submission on March 23, 2020. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1210.

Submission Details

510(k) Number K200744 FDA.gov
FDA Decision Cleared SESE
Date Received March 23, 2020
Decision Date April 21, 2020
Days to Decision 29 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code KRA — Catheter, Continuous Flush
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1210

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