Guided Measurement Catheter (GMC)

FDA 510(k) K091780 · Mediguide, Ltd.

Substantially Equivalent

510(k) numberK091780

Submission

Device name
Guided Measurement Catheter (GMC)
Applicant
Mediguide, Ltd.
Washington, DC, US
Received
June 17, 2009
Decision date
October 16, 2009
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

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

Other 510(k)s with product code DQO

510(k)DeviceApplicantDecision
K261455Arterial Pressure Monitoring Set/TrayDQO · Traditional Spectrum Vascular06/26/2026SE
K252702Bioptimal Pulmonary Artery Monitoring Catheter (TD2502NF, TD2502NGF, TD2502NDF…DQO · Traditional Bioptimal International Pte. , Ltd.05/28/2026SE
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
K102905Guided Medical Positioning System II (GMPS II)DQK · Special 10/29/2010SE
K091781Guided Medical Positioning System (GMPS)DQK · Traditional 10/16/2009SE

Questions and answers

When was Guided Measurement Catheter (GMC) cleared by the FDA?

Guided Measurement Catheter (GMC) (K091780) received a 510(k) decision of Substantially Equivalent on October 16, 2009, 121 days after the submission was received.

What is the product code of K091780?

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