Cleared Traditional

K182399 - Park Blade Septostomy Catheter

K182399 is an FDA 510(k) clearance for Park Blade Septostomy Catheter, manufactured by Cook Incorporated. The device is a Class 2 Cardiovascular device with product code DXF cleared through the Traditional 510(k) pathway after a 212-day FDA review.

K182399 · Cook Incorporated · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2019
Decision
212d
Days
Class 2
Risk

K182399 is an FDA 510(k) clearance for the Park Blade Septostomy Catheter. Classified as Catheter, Septostomy (product code DXF), Class II - Special Controls.

Submitted by Cook Incorporated (Bloomington, US). The FDA issued a Cleared decision on April 4, 2019 after a review of 212 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5175 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Cook Incorporated devices

FDA 510(k) Submission Details - K182399

510(k) Number K182399 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
87d slower than avg
Panel avg: 125d · This submission: 212d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXF Device Classification - Class 2, Special Controls

Product Code DXF Catheter, Septostomy
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5175
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DXF Catheter, Septostomy

All 20
Devices cleared under the same product code (DXF) and FDA review panel - the closest regulatory comparables to K182399.
Cross Vascular RF Transseptal Needle, Cross Vascular Connection Cable
K232852 · Cross Vascular, Inc. · Oct 2023
Fogarty Dilation Atrioseptostomy Catheter, Miller Balloon Atrioseptostomy Catheter
K221528 · Edwards Lifesciences, LLC · Aug 2022
Z-6 Atrioseptostomy Catheter
K211910 · NuMED, Inc. · Jul 2021
ProTrack RF Anchor Wire
K150709 · Baylis Medical Company, Inc. · Jun 2015
NRG TRANSSEPTAL NEEDLE
K073326 · Baylis Medical Co., Inc. · May 2008
TORONTO RF SEPTOSTOMY CATHETER, MODEL TSC-50-75
K031949 · Baylis Medical Co., Inc. · Dec 2003