Advanced Catheter Systems Coronary Guid

FDA 510(k) K813624 · Advanced Catheter Systems

Substantially Equivalent

510(k) numberK813624

Submission

Device name
Advanced Catheter Systems Coronary Guid
Applicant
Advanced Catheter Systems
Walker, MI, US
Received
December 29, 1981
Decision date
January 22, 1982
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
DQO – Catheter, Intravascular, Diagnostic
Device class
Class II (moderate risk)
Regulation
21 CFR 870.1200
Specialty
Cardiovascular

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K261455Arterial Pressure Monitoring Set/TrayDQO · Traditional Spectrum Vascular06/26/2026SE
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K254278Arterial Pressure Monitoring Set/TrayDQO · Special Spectrum Vascular03/25/2026SE
K250751DualView CatheterDQO · Traditional Terumo Corporation07/17/2025SE
K242966Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging CatheterDQO · Traditional Gentuity, LLC01/31/2025SE
K242420pNOVUS 21 MicrocatheterDQO · Traditional Phenox, Ltd.11/12/2024SE
K233268Impress Angiographic CatheterDQO · Special Merit Medical Systems, Inc.05/22/2024SE
K233975Zoom 6F Insert CathetersDQO · Traditional Imperative Care, Inc.04/02/2024SE
K232536Soldier MicrocatheterDQO · Traditional Embolx, Inc.02/23/2024SE
K232573INFINITI™ Ambi Angiographic CatheterDQO · Traditional Cordis US Corp11/21/2023SE

More from Cordis US Corp

510(k)DeviceDecision
K813577Pressure Indicator-RegulatorDQO · Traditional 01/29/1982SE
K813623Simpson-Robert Coronary Guiding CathetDQO · Traditional 01/22/1982SE
K813622IndeflatorDQO · Traditional 01/22/1982SE
K813578Hemostatic Side-Arm AdapterDYG · Traditional 01/18/1982SE

Questions and answers

When was Advanced Catheter Systems Coronary Guid cleared by the FDA?

Advanced Catheter Systems Coronary Guid (K813624) received a 510(k) decision of Substantially Equivalent on January 22, 1982, 24 days after the submission was received.

What is the product code of K813624?

The FDA product code is DQO – Catheter, Intravascular, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 870.1200.