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
Combination Product No
PCCP Authorized No
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 Consultant

Inneuroco
Marianne Grunwaldt

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - DQY Catheter, Percutaneous

All 845
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K161262.
Navien Intracranial Support Catheter
K161152 · Micro Therapeutics, Inc. d/b/a ev3 Neurovascular · Oct 2016
TrailBlazer Angled Support Catheter
K162384 · Medtronic Vascular, Inc.(Formerly Ev3 Inc.) · Sep 2016
Surefire Guiding Catheter
K162359 · Surefire Medical, Inc. · Sep 2016
TorqVue Low Profile Delivery Catheter
K162228 · Aga Medical Corporation (Wholly Owned by St.Jude Medical Cor · Sep 2016
ASAHI Corsair Pro
K161126 · Asahi Intecc Co., Ltd. · Aug 2016
SIDEKICK and USHER Support Catheters
K161986 · Bard Peripheral Vascular, Inc. · Aug 2016