Cleared Traditional

K161901 - TrapLiner catheter

K161901 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 Traditional 510(k) pathway after a 207-day FDA review.

K161901 · Vascular Solutions, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2017
Decision
207d
Days
Class 2
Risk

K161901 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 February 3, 2017 after a review of 207 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1250 - 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

FDA 510(k) Submission Details - K161901

510(k) Number K161901 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 11, 2016
Decision Date February 03, 2017
Days to Decision 207 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
82d slower than avg
Panel avg: 125d · This submission: 207d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 650
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K161901.
Venture 038 catheter
K171335 · Vascular Solutions, Inc. · Jun 2017
Reverse 021 Micro Catheter, Reverse 027 Micro Catheter
K171268 · Micro Therapeutics, Inc. d/b/a ev3 Neurovascular · May 2017
Guidezilla II Guide Extension Catheter
K163314 · Boston Scientific Corporation · Mar 2017
Twin-Pass Torque
K162467 · Vascular Solutions, Inc. · Feb 2017
YOGA Microcatheter
K162563 · Codman & Shurtleff, Inc. · Jan 2017
Navien Intracranial Support Catheter
K161152 · Micro Therapeutics, Inc. d/b/a ev3 Neurovascular · Oct 2016