Cleared Traditional

Park Blade Septostomy Catheter

K182399 · Cook Incorporated · Cardiovascular
Apr 2019
Decision
212d
Days
Class 2
Risk

About This 510(k) Submission

K182399 is an FDA 510(k) clearance for the Park Blade Septostomy Catheter, a Catheter, Septostomy (Class II — Special Controls, product code DXF), submitted by Cook Incorporated (Bloomington, US). The FDA issued a Cleared decision on April 4, 2019, 212 days after receiving the submission on September 4, 2018. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5175.

Submission Details

510(k) Number K182399 FDA.gov
FDA Decision Cleared SESE
Date Received September 04, 2018
Decision Date April 04, 2019
Days to Decision 212 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DXF — Catheter, Septostomy
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.5175

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