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FDA 510(k)

URSA ANGIOGRAPHIC CATHETER

K-Number: K123818 · 2013-03-04

ApplicantCurative Medical Technology, Inc.
Decision Date2013-03-04
Product CodeDQO
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

URSA ANGIOGRAPHIC CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Curative Medical Technology, Inc.. It received FDA 510(k) clearance on 2013-03-04 under 510(k) number K123818. 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 URSA ANGIOGRAPHIC CATHETER?

URSA ANGIOGRAPHIC CATHETER is a medical device that received FDA 510(k) clearance on 2013-03-04. The listed applicant is Curative Medical Technology, Inc.. The 510(k) number is K123818.

When did URSA ANGIOGRAPHIC CATHETER receive FDA 510(k) clearance?

URSA ANGIOGRAPHIC CATHETER received FDA 510(k) clearance on 2013-03-04, under 510(k) number K123818.

Who is the listed applicant for URSA ANGIOGRAPHIC CATHETER?

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

What is the FDA product code for URSA ANGIOGRAPHIC CATHETER?

The FDA product code for URSA ANGIOGRAPHIC CATHETER 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 Curative Medical Technology, 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.

K090427URSA ANGIOGRAPHIC 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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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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