Cleared Traditional

K172014 - Wedge Microcatheter

K172014 is an FDA 510(k) clearance for Wedge Microcatheter, manufactured by MicroVention, Inc.. The device is a Class 2 Cardiovascular device with product code DQY cleared through the Traditional 510(k) pathway after a 276-day FDA review.

K172014 · MicroVention, Inc. · Cardiovascular device
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Apr 2018
Decision
276d
Days
Class 2
Risk

K172014 is an FDA 510(k) clearance for the Wedge Microcatheter. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by MicroVention, Inc. (Tistin, US). The FDA issued a Cleared decision on April 5, 2018 after a review of 276 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 MicroVention, Inc. devices

FDA 510(k) Submission Details - K172014

510(k) Number K172014 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 2017
Decision Date April 05, 2018
Days to Decision 276 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
151d slower than avg
Panel avg: 125d · This submission: 276d
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 646
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K172014.
Route 92 Medical Access System
K180201 · Route 92 Medical, Inc. · May 2018
XableCath Support Catheter Product Family
K180986 · Xablecath, Inc. · May 2018
Wingman 35 Crossing Catheter
K173661 · Reflow Medical, Inc. · Apr 2018
TrapLiner catheter
K180088 · Vascular Solutions, Inc. · Apr 2018
Merit Pursue Microcatheter
K173548 · Merit Medical Systems, Inc. · Mar 2018
NaviCross 0.018
K173799 · Terumo Corporation · Mar 2018