Cleared Traditional

K050168 - LANGSTON DUAL LUMEN PRESSURE MONITORING...

K050168 is the FDA 510(k) clearance for LANGSTON DUAL LUMEN PRESSURE MONITORING... by Vascular Solutions, Inc.. It is a Class 2 Cardiovascular device (product code DQO) cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K050168 · Vascular Solutions, Inc. · Cardiovascular device
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May 2005
Decision
112d
Days
Class 2
Risk

K050168 is an FDA 510(k) clearance for the LANGSTON DUAL LUMEN PRESSURE MONITORING 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 May 18, 2005 after a review of 112 days - within the typical 510(k) review window.

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 K050168 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 26, 2005
Decision Date May 18, 2005
Days to Decision 112 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
13d faster than avg
Panel avg: 125d · This submission: 112d
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 269
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K050168.
LANGSTON DUAL LUMEN PRESSURE MONITORING CATHETER
K051395 · Vascular Solutions, Inc. · Jun 2005
MEDRAD VANGUARD DX ANGIOGRAPHIC CATHETER
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ATLANTIS PV
K050684 · Boston Scientific Corp · May 2005
ATLANTIS SR PRO2 CORONARY IMAGING CATHETER, MODEL 39014
K050577 · Boston Scientific Corp · Mar 2005
VASCULAR SOLUTIONS LANGSTON DUAL LUMEN PIGTAIL CATHETER (DLP)
K041909 · Vascular Solutions, Inc. · Sep 2004
PTA, PTV, ATRIOSEPTOSTOMY, ANGIOGRAPHIC, SIZING CATHETERS
K040830 · NuMED, Inc. · Jun 2004