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FDA 510(k)

GUIDED MEASUREMENT CATHETER (GMC)

K-Number: K091780 · 2009-10-16

ApplicantMediguide, Ltd.
Decision Date2009-10-16
Product CodeDQO
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

GUIDED MEASUREMENT CATHETER (GMC) is the device name listed in this FDA 510(k) record. The listed applicant is Mediguide, Ltd.. It received FDA 510(k) clearance on 2009-10-16 under 510(k) number K091780. The device is classified under product code DQO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GUIDED MEASUREMENT CATHETER (GMC)?

GUIDED MEASUREMENT CATHETER (GMC) is a medical device that received FDA 510(k) clearance on 2009-10-16. The listed applicant is Mediguide, Ltd.. The 510(k) number is K091780.

When did GUIDED MEASUREMENT CATHETER (GMC) receive FDA 510(k) clearance?

GUIDED MEASUREMENT CATHETER (GMC) received FDA 510(k) clearance on 2009-10-16, under 510(k) number K091780.

Who is the listed applicant for GUIDED MEASUREMENT CATHETER (GMC)?

The FDA 510(k) record lists Mediguide, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GUIDED MEASUREMENT CATHETER (GMC)?

The FDA product code for GUIDED MEASUREMENT CATHETER (GMC) is DQO.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Mediguide, Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K102905GUIDED MEDICAL POSITIONING SYSTEM II (GMPS II)K091781GUIDED MEDICAL POSITIONING SYSTEM (GMPS)

Related Devices (Code: DQO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261455Arterial Pressure Monitoring Set/TraySpectrum VascularK252702Bioptimal Pulmonary Artery Monitoring Catheter (TD2502NF, TD2502NGF, TD2502NDF, TD2502NCF, TD2502NCGF, TD2502NDGF, TD2502NDCF, TD2502NDCGF, TD2502NXCF, TD2502NDXF, TD2502NXCGF, TD2502NDXGF, TD2502NDXCF, TD2502NDXCGF, TD2502-110NF, TD2502-110NGF, TD2502-110NDF, TD2502-110NCF, TD2502-110NDGF, TD2502-110NDCF, TD2502-110NCGF, TD2502-110NDCGF, TD2502-110NXF, TD2502-110NXGF, TD2502-110NDXF, TD2502-110NXCF, TD2502-110NDXGF, TD2502-110NDXCF ,TD2502-110NXCGF, TD2502-110NDXCGF, TD2602NF, TD2602NBioptimal International Pte. , Ltd.K254278Arterial Pressure Monitoring Set/TraySpectrum VascularK250751DualView CatheterTerumo CorporationK242966Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging CatheterGentuity, LLCK242420pNOVUS 21 MicrocatheterPhenox, Ltd.

Official Source

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