Cleared Traditional

K161152 - Navien Intracranial Support Catheter

K161152 is the FDA 510(k) clearance for Navien Intracranial Support Catheter by Micro Therapeutics, Inc. d/b/a ev3 Neurovascular. It is a Class 2 Cardiovascular device (product code DQY) cleared through the Traditional 510(k) pathway after a 170-day FDA review.

K161152 · Micro Therapeutics, Inc. d/b/a ev3 Neurovascular · Cardiovascular device
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Oct 2016
Decision
170d
Days
Class 2
Risk

K161152 is an FDA 510(k) clearance for the Navien Intracranial Support Catheter. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Micro Therapeutics, Inc. d/b/a ev3 Neurovascular (Irvine, US). The FDA issued a Cleared decision on October 12, 2016 after a review of 170 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 Micro Therapeutics, Inc. d/b/a ev3 Neurovascular devices

Submission Details

510(k) Number K161152 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 25, 2016
Decision Date October 12, 2016
Days to Decision 170 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
45d slower than avg
Panel avg: 125d · This submission: 170d
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 506
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K161152.
TrapLiner catheter
K161901 · Vascular Solutions, Inc. · Feb 2017
Twin-Pass Torque
K162467 · Vascular Solutions, Inc. · Feb 2017
YOGA Microcatheter
K162563 · Codman & Shurtleff, Inc. · Jan 2017
ASAHI Corsair Pro
K161126 · Asahi Intecc Co., Ltd. · Aug 2016
ASAHI Corsair Armet
K161362 · Asahi Intecc Co., Ltd. · Jun 2016
ASAHI Corsair Armet
K152249 · Asahi Intecc Co., Ltd. · Mar 2016