Cleared Traditional

White Sizing Catheter, Aurous Centimeter Sizing Catheter, Cava Vessel Sizing Catheter (K162448) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K162448 · Cook Incorporated · Cardiovascular device
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May 2017
Decision
267d
Days
Class 2
Risk

K162448 is an FDA 510(k) clearance for the White Sizing Catheter, Aurous Centimeter Sizing Catheter, Cava Vessel Sizing .... 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 May 26, 2017 after a review of 267 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

Submission Details

510(k) Number K162448 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 01, 2016
Decision Date May 26, 2017
Days to Decision 267 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
142d slower than avg
Panel avg: 125d · This submission: 267d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 204
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K162448.
Royal Flush Catheter
K171264 · Cook Incorporated · Jan 2018
Langston dual lumen catheter
K170544 · Vascular Solutions, Inc. · Nov 2017
Beacon Tip Torcon NB Advantage Catheter, Slip-Cath Beacon Tip Catheter and Shuttle Select Slip-Cath Catheter, Beacon Tip Centimeter Sizing Catheter, Beacon Tip Cava Vessel Sizing Catheter, Beacon Tip White Vessel Sizing Catheter
K173289 · Cook Incorporated · Nov 2017
Soft-Vu, Mariner, Accu-Vu and AngioOptic Catheters
K161596 · AngioDynamics, Inc. · Apr 2017
Medline Waste Station
K160660 · Medline Industries, Inc. · Jan 2017
NAMIC ClearaCIL Contrast Injection Lines
K163141 · AngioDynamics, Inc. · Jan 2017