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FDA 510(k)

METRICATH SYSTEM

K-Number: K042685 · 2004-11-18

ApplicantAngiometrx, Inc.
Decision Date2004-11-18
Product CodeDQO
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

METRICATH SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Angiometrx, Inc.. It received FDA 510(k) clearance on 2004-11-18 under 510(k) number K042685. 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 METRICATH SYSTEM?

METRICATH SYSTEM is a medical device that received FDA 510(k) clearance on 2004-11-18. The listed applicant is Angiometrx, Inc.. The 510(k) number is K042685.

When did METRICATH SYSTEM receive FDA 510(k) clearance?

METRICATH SYSTEM received FDA 510(k) clearance on 2004-11-18, under 510(k) number K042685.

Who is the listed applicant for METRICATH SYSTEM?

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

What is the FDA product code for METRICATH SYSTEM?

The FDA product code for METRICATH SYSTEM 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.

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Other records listing Angiometrx, Inc. 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.

K051042METRICATH GEMINI-P BALLOON CATHETER, MODELS RX2515S-P, RX3015S-P, RX3515S-P, RX4015S-P, METRICATH CONSOLE, MODEL 1000K024000METRICATH SYSTEM COMPRISED OF METRICATH 1000 CONSOLE & METRICATH BALLOON CATHETER

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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