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URSA Angiographic Catheter

by Curative Medical Technology, Inc. 510(k)

Active United States

510(k) K090427

Overview

The URSA Angiographic Catheter is a diagnostic catheter classified under the Device Type DQO (Angiographic Catheters) per FDA nomenclature. It is designed for selective catheterization of blood vessels to facilitate the delivery of radiopaque contrast media during angiographic imaging procedures, enabling visualization of the vascular system.

This catheter is intended for single-use in interventional radiology and cardiology settings. Supplied sterile and packaged for aseptic use, it features a braided shaft construction with a 3-layer design for enhanced torque transmission and structural support. The device is FDA-cleared under 510(k) K090427, adhering to traditional review standards for cardiovascular diagnostic tools. No MRI safety labeling is specified.

AI-generated from registry data, 1 Oct 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK090427 Date29 Jan 2010ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
DQO
Device Class
Class II
Regulation
21 CFR Part 870.1200
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Other devices from Curative Medical Technology, Inc.

Questions

  • What is the URSA Angiographic Catheter used for?

    The URSA Angiographic Catheter is designed for selective catheterization of blood vessels during angiographic imaging. It facilitates the delivery of radiopaque contrast media, allowing clinicians to visualize the vascular system with clarity. This is particularly useful in interventional radiology and cardiology procedures where detailed imaging of blood vessels is required.

  • How is the URSA Angiographic Catheter supplied and prepared for use?

    The URSA Angiographic Catheter is supplied sterile and packaged for aseptic use, ensuring readiness for immediate clinical application. The packaging is designed to maintain sterility until the time of use, reducing the risk of contamination in procedural settings.

  • Is the URSA Angiographic Catheter intended for single-use or reuse?

    The URSA Angiographic Catheter is explicitly designed for single-use only. This design choice aligns with best practices in medical device safety and infection control, minimizing the risk of cross-contamination between patients and ensuring consistent performance.

  • What structural features distinguish the URSA Angiographic Catheter?

    The URSA Angiographic Catheter features a braided shaft with a 3-layer design. This construction enhances torque transmission, providing clinicians with better control during catheterization, and offers improved structural support for navigating complex vascular pathways.

  • Does the URSA Angiographic Catheter have any specific safety considerations for use?

    The URSA Angiographic Catheter does not carry MRI safety labeling, meaning it should not be used in MRI environments. Clinicians should ensure compatibility with imaging modalities and procedural settings before use, adhering to standard safety protocols for angiographic catheters.