Cleared Traditional

K171672 - 065 Zenith

K171672 is an FDA 510(k) clearance for 065 Zenith, manufactured by Inneuroco, Inc.. The device is a Class 2 Cardiovascular device with product code DQY cleared through the Traditional 510(k) pathway after a 135-day FDA review.

K171672 · Inneuroco, Inc. · Cardiovascular device
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Oct 2017
Decision
135d
Days
Class 2
Risk

K171672 is an FDA 510(k) clearance for the 065 Zenith, 074 Zenith. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Inneuroco, Inc. (Sunrise, US). The FDA issued a Cleared decision on October 19, 2017 after a review of 135 days - within the typical 510(k) review window.

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 Inneuroco, Inc. devices

FDA 510(k) Submission Details - K171672

510(k) Number K171672 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 06, 2017
Decision Date October 19, 2017
Days to Decision 135 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
10d slower than avg
Panel avg: 125d · This submission: 135d
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 622
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K171672.
Microcatheter
K173560 · Surmodics,Inc. · Jan 2018
Attain Assist CS Access Catheter
K171819 · Creganna Medical Also Doing Business AS Ceganna Tactx Medica · Jan 2018
GuideLiner V3 Catheter
K172090 · Vascular Solutions, Inc. · Oct 2017
MAMBA and MAMBA FLEX Microcatheters
K171452 · Boston Scientific Corporation · Aug 2017
AXS Offset Delivery Assist Catheter
K163259 · Stryker Neurovascular · Jul 2017
Rubicon 14, 18 and 35 Support Catheters
K171913 · Boston Scientific Corporation · Jul 2017