Cleared Special

Instylla Microcatheter 1.2

K210808 · Instylla, Inc. · Cardiovascular
Apr 2021
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K210808 is an FDA 510(k) clearance for the Instylla Microcatheter 1.2, a Catheter, Continuous Flush (Class II — Special Controls, product code KRA), submitted by Instylla, Inc. (Bedford, US). The FDA issued a Cleared decision on April 15, 2021, 29 days after receiving the submission on March 17, 2021. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1210.

Submission Details

510(k) Number K210808 FDA.gov
FDA Decision Cleared SESE
Date Received March 17, 2021
Decision Date April 15, 2021
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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