Cleared Traditional

Wedge Microcatheter (K172014) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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.

Device Classification

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 390
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