Cleared Traditional

Langston dual lumen catheter (K170544) - FDA 510(k) Clearance

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

K170544 · Vascular Solutions, Inc. · Cardiovascular device
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Nov 2017
Decision
266d
Days
Class 2
Risk

K170544 is an FDA 510(k) clearance for the Langston dual lumen catheter. Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by Vascular Solutions, Inc. (Minneapolis, US). The FDA issued a Cleared decision on November 17, 2017 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 Vascular Solutions, Inc. devices

Submission Details

510(k) Number K170544 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 24, 2017
Decision Date November 17, 2017
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.

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 194
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K170544.
Surefire Spark Infusion System
K180677 · Surefire Medical, Inc. · Apr 2018
SeQure® NF and SeQure® Microcatheters
K173430 · Accurate Medical Therapeutics, Ltd. · Jan 2018
Royal Flush Catheter
K171264 · Cook Incorporated · Jan 2018
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
White Sizing Catheter, Aurous Centimeter Sizing Catheter, Cava Vessel Sizing Catheter
K162448 · Cook Incorporated · May 2017
Soft-Vu, Mariner, Accu-Vu and AngioOptic Catheters
K161596 · AngioDynamics, Inc. · Apr 2017