Cleared Special

K180088 - TrapLiner catheter

K180088 is an FDA 510(k) clearance for TrapLiner catheter, manufactured by Vascular Solutions, Inc.. The device is a Class 2 Cardiovascular device with product code DQY cleared through the Special 510(k) pathway after a 82-day FDA review.

K180088 · Vascular Solutions, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2018
Decision
82d
Days
Class 2
Risk

K180088 is an FDA 510(k) clearance for the TrapLiner catheter. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Vascular Solutions, Inc. (Minneapolis, US). The FDA issued a Cleared decision on April 4, 2018 after a review of 82 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 Vascular Solutions, Inc. devices

FDA 510(k) Submission Details - K180088

510(k) Number K180088 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 12, 2018
Decision Date April 04, 2018
Days to Decision 82 days
Submission Type Special
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
43d faster than avg
Panel avg: 125d · This submission: 82d
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 619
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K180088.
XableCath Support Catheter Product Family
K180986 · Xablecath, Inc. · May 2018
Wingman 35 Crossing Catheter
K173661 · Reflow Medical, Inc. · Apr 2018
Wedge Microcatheter
K172014 · MicroVention, Inc. · Apr 2018
Merit Pursue Microcatheter
K173548 · Merit Medical Systems, Inc. · Mar 2018
NaviCross 0.018
K173799 · Terumo Corporation · Mar 2018
Zenith Support, 95 cm, Zenith Support, 105 cm, Zenith Support, 115 cm
K173709 · Inneuroco, Inc. · Jan 2018