Cleared Traditional

Instylla Microcatheter

K191731 · Instylla, Inc. · Cardiovascular
Aug 2019
Decision
46d
Days
Class 2
Risk

About This 510(k) Submission

K191731 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 August 13, 2019, 46 days after receiving the submission on June 28, 2019. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1210.

Submission Details

510(k) Number K191731 FDA.gov
FDA Decision Cleared SESE
Date Received June 28, 2019
Decision Date August 13, 2019
Days to Decision 46 days
Submission Type Traditional
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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