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Advanced Catheter Systems Coronary Guid

by Advanced Catheter Systems

510(k) K813624

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 NumberK813624 Date22 Jan 1982ClearedStatusActive

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  • Withdrawn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
DQO
Device Class
Class II
Regulation
21 CFR Part 870.1200
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 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 Coronary Guid Catheter System is a guide extension catheter designed for coronary intervention procedures. It is classified as a coronary guide catheter under the product code DQO, intended to assist in navigating complex coronary arteries during percutaneous coronary intervention (PCI). This device supports deep intubation of coronary vessels, facilitating access in challenging anatomical scenarios such as calcified lesions, tortuous vessels, or chronic total occlusions.

This system is supplied as a single-use medical device and is regulated under FDA 510(k) clearance (K813624) with a Traditional review pathway. It is intended for use in cardiac catheterization laboratories and is not MRI-compatible. The device is manufactured by Advanced Catheter Systems and adheres to FDA-substantiated equivalence standards for cardiovascular devices. Storage and handling should follow sterile medical device protocols.

Other devices from Advanced Catheter Systems

Questions

AI-generated answers, 1 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 Coronary Guid Catheter System used for?

    The Coronary Guid Catheter System is designed specifically for coronary intervention procedures, particularly percutaneous coronary intervention (PCI). It assists in navigating and accessing challenging coronary arteries, such as those with calcified lesions, tortuous paths, or chronic total occlusions. By extending guide catheter reach, it enables deeper intubation, improving procedural success in complex anatomical scenarios.

  • Is the Coronary Guid Catheter System single-use or reusable?

    This device is supplied as a single-use medical device. Single-use design ensures sterility and reduces the risk of cross-contamination between patients, which is critical in cardiac catheterization laboratories where infection control is paramount.

  • Where should the Coronary Guid Catheter System be stored?

    The device must be stored and handled according to sterile medical device protocols. This includes maintaining its sterile packaging until immediate use and adhering to manufacturer guidelines for environmental conditions (e.g., temperature, humidity) to preserve its integrity and functionality.

  • Can this catheter be used in patients with chronic total occlusions?

    Yes, the Coronary Guid Catheter System is explicitly designed to support deep intubation in chronic total occlusions (CTOs). Its extended reach and design help navigate the complex anatomy associated with CTOs, facilitating better access for interventional tools during PCI.

  • Is the Coronary Guid Catheter System MRI-compatible?

    No, the Coronary Guid Catheter System is not MRI-compatible. This limitation is important for clinicians to note, as MRI use may not be feasible for patients who require further imaging or monitoring post-procedure.