Cleared Traditional

K182399 - Park Blade Septostomy Catheter

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

K182399 · Cook Incorporated · Cardiovascular device
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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

Submission Details

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.

Device Classification

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 15
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
PTA, PTV, ATRIOSEPTOSTOMY, ANGIOGRAPHIC, SIZING CATHETERS
K011557 · NuMED, Inc. · Jul 2001
NUMED Z-5 ATRIOSEPTOSTOMY CATHETER
K001804 · NuMED, Inc. · Jul 2000
REGULATED PRESSURE INJECTOR
K860806 · Target Therapeutics · Mar 1986