Cleared Traditional

065 Zenith, 074 Zenith (K171672) - FDA 510(k) Clearance

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

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

Submission Details

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.

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 321
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
Rubicon 14, 18 and 35 Support Catheters
K171913 · Boston Scientific Corporation · Jul 2017
YOGA Microcatheter, 0.032, 150cm, Back Up and Extra Back Up
K171653 · Codman & Shurtleff, Inc. · Jul 2017