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Super Distal Access (SDA)

by Inneuroco, Inc.

510(k) K161262

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK161262 Date19 Sep 2016ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
DQY
Device Class
Class II
Regulation
21 CFR Part 870.1250
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Super Distal Access (SDA) is a large bore cerebral aspiration catheter designed for endovascular procedures. It facilitates the removal of thrombi from cerebral arteries, particularly in cases of acute ischemic stroke. The device's design allows for enhanced navigation and access to distal cerebral vasculature.

The Super Distal Access (SDA) is indicated for the introduction of interventional devices into the peripheral and neuro vasculature. It is manufactured by Inneuroco, Inc. with model number GEN-10. The device received FDA 510(k) clearance with number K161262 on 2016-09-19, deemed substantially equivalent.

Other devices from Inneuroco, Inc.

See all devices from Inneuroco, Inc. →

Questions

AI-generated answers, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Super Distal Access (SDA) catheter used for?

    The Super Distal Access (SDA) is a large bore cerebral aspiration catheter designed for endovascular procedures to facilitate removal of thrombi from cerebral arteries, particularly in cases of acute ischemic stroke. It also allows for the introduction of interventional devices into peripheral and neuro vasculature.

  • How is the Super Distal Access (SDA) supplied and is it single-use?

    The device is supplied as a single-use catheter. Each unit is designed for one procedure only to ensure safety and effectiveness. The manufacturer, Inneuroco, Inc., provides detailed instructions for handling and disposal of the device after use.

  • What are the specifications and regulatory status of the Super Distal Access (SDA)?

    The Super Distal Access (SDA) has model number GEN-10 and received FDA 510(k) clearance with number K161262 on September 19, 2016, deemed substantially equivalent. It is classified under product code DQY and reviewed by the Cardiovascular advisory committee.

  • How should the Super Distal Access (SDA) be stored?

    The device should be stored in a clean, dry environment at room temperature as specified by the manufacturer. Exposure to extreme temperatures, humidity, or direct sunlight should be avoided to maintain the integrity of the catheter until use.