Cleared Special

K080360 - ENDOLOGIX VISIFLEX DUAL LUMEN CATHETER

K080360 is an FDA 510(k) clearance for ENDOLOGIX VISIFLEX DUAL LUMEN CATHETER, manufactured by Endologix, Inc.. The device is a Class 2 Cardiovascular device with product code DQY cleared through the Special 510(k) pathway after a 57-day FDA review.

K080360 · Endologix, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2008
Decision
57d
Days
Class 2
Risk

K080360 is an FDA 510(k) clearance for the ENDOLOGIX VISIFLEX DUAL LUMEN CATHETER. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Endologix, Inc. (Irvine, US). The FDA issued a Cleared decision on April 8, 2008 after a review of 57 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1250 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Endologix, Inc. devices

FDA 510(k) Submission Details - K080360

510(k) Number K080360 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 11, 2008
Decision Date April 08, 2008
Days to Decision 57 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
68d faster than avg
Panel avg: 125d · This submission: 57d
Pathway characteristics
Modification to existing cleared device.

DQY Device Classification - Class 2, Special Controls

Product Code DQY Catheter, Percutaneous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
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 - DQY Catheter, Percutaneous

All 659
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K080360.
MODIFIED HD GUIDE CATHETER
K080583 · Concentric Medical, Inc. · Jul 2008
NUCLEUS-X, MODEL 230X
K081680 · NuMED, Inc. · Jul 2008
SCOUTPRO CS LEAD INTRODUCER SYSTEM
K080988 · Biotronik, Inc. · May 2008
SCOUTPRO 8F, 7F AND SLITTER TOOL ADVANCED
K072329 · Biotronik, Inc. · Mar 2008
ACUITY UNIVERSAL CUTTER
K080154 · Cardiac Pacemakers, Inc. · Mar 2008
ADVANCE 18LP PTA DILATATION CATHETER
K073378 · Cook, Inc. · Dec 2007