Cleared Traditional

K181722 - Polyethylene Catheter

K181722 is an FDA 510(k) clearance for Polyethylene Catheter, manufactured by Cook Incorporated. The device is a Class 2 Cardiovascular device with product code DQO cleared through the Traditional 510(k) pathway after a 266-day FDA review.

K181722 · Cook Incorporated · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Mar 2019
Decision
266d
Days
Class 2
Risk

K181722 is an FDA 510(k) clearance for the Polyethylene Catheter. Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by Cook Incorporated (Bloomington, US). The FDA issued a Cleared decision on March 22, 2019 after a review of 266 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1200 - 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 - K181722

510(k) Number K181722 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 29, 2018
Decision Date March 22, 2019
Days to Decision 266 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
141d slower than avg
Panel avg: 125d · This submission: 266d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQO Device Classification - Class 2, Special Controls

Product Code DQO Catheter, Intravascular, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1200
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 - DQO Catheter, Intravascular, Diagnostic

All 403
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K181722.
Dragonfly OpStar™ Imaging Catheter, AptiVue™ Software version E.5.1
K192019 · Abbott Medical · Nov 2019
Bendit2.7 Steerable Microcatheter
K190126 · Bend IT Technologies, Ltd. · Aug 2019
Impress Angiographic Catheter
K191608 · Merit Medical Systems, Inc. · Jul 2019
Arterial Pressure Monitoring Set/Tray
K180846 · Cook Incorporated · Dec 2018
Arterial Pressure Monitoring Set/Tray
K180792 · Cook Incorporated · Nov 2018
Polyethylene Catheter
K180286 · Cook Incorporated · Oct 2018