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Kerberos Occluding Guide Catheter and Accessories

by Kerberos Proximal Solutions, Inc.

510(k) K041151

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 NumberK041151 Date22 Jul 2004ClearedStatusActive

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  • Withdrawn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, 23 Sep 2026

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

The Kerberos Occluding Guide Catheter and Accessories is a catheter system designed to facilitate the placement and guidance of intravascular catheters within selected peripheral, cardiovascular and neurovascular vessels. It provides an occluding guide that serves as a conduit for delivering therapeutic devices such as stents.

The system received traditional FDA 510(k) clearance (K041151, product code DQY) on 22 July 2004 and is classified under regulation 870.1250. It is supplied in a range of sizes to accommodate different patient anatomies and is compatible with standard interventional tools. The device is intended for use in interventional procedures as described by the manufacturer.

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