Cleared Traditional

Super Distal Access (SDA) (K161262) - FDA 510(k) Clearance

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

K161262 · Inneuroco, Inc. · Cardiovascular device
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Sep 2016
Decision
137d
Days
Class 2
Risk

K161262 is an FDA 510(k) clearance for the Super Distal Access (SDA). Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Inneuroco, Inc. (Sunrise, US). The FDA issued a Cleared decision on September 19, 2016 after a review of 137 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 K161262 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 05, 2016
Decision Date September 19, 2016
Days to Decision 137 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
12d slower than avg
Panel avg: 125d · This submission: 137d
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 K161262.
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
Stingray LP Catheter
K152401 · Boston Scientific Corporation · Dec 2015
Coda LP Balloon Catheter
K150970 · Cook Incorporated · May 2015
ENVOY DISTAL ACCESS (DA) GUIDING CATHETER, 6F, 95CM & 105CM, STRAIGHT & XB, MPD & XB, MPC & XB
K140080 · Codman & Shurtleff, Inc. · Apr 2014