Cleared Traditional

K161262 - Super Distal Access (SDA)

K161262 is an FDA 510(k) clearance for Super Distal Access (SDA), 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 137-day FDA review.

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

FDA 510(k) Submission Details - K161262

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.

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 K161262.
Twin-Pass Torque
K162467 · Vascular Solutions, Inc. · Feb 2017
YOGA Microcatheter
K162563 · Codman & Shurtleff, Inc. · Jan 2017
Navien Intracranial Support Catheter
K161152 · Micro Therapeutics, Inc. d/b/a ev3 Neurovascular · Oct 2016
ASAHI Corsair Pro
K161126 · Asahi Intecc Co., Ltd. · Aug 2016
SIDEKICK and USHER Support Catheters
K161986 · Bard Peripheral Vascular, Inc. · Aug 2016
ASAHI Corsair Armet
K161362 · Asahi Intecc Co., Ltd. · Jun 2016