Vertex Monitoring Catheter

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K823253 ↗

FDA Product Code

DXT

Device Class

Class II

Regulation

21 CFR Part 870.1650

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Backstop Valve W/Side Arm

  Class II

  FDA 510(k) K823190 Active Cleared 30 Dec 1982

• Polyethylene Monitoring Connectors

  Class II

  FDA 510(k) K830420 Active Cleared 28 Feb 1983

• Ultra-Asept Angiographic Syringe/Spare

  Class II

  FDA 510(k) K823256 Active Cleared 30 Dec 1982

• Eschmann Dilation Catheter

  Not classified

  FDA 510(k) K833742 Active Cleared 24 Apr 1984

• Polyethylene Cardiovascular Catheter

  Class II

  FDA 510(k) K822594 Active Cleared 28 Sep 1982

• Percutaneous Catheter Introducer Set

  Class II

  FDA 510(k) K822593 Active Cleared 28 Sep 1982

See all devices from Vertex Medical Corp. →

• What types of procedures is the Vertex Monitoring Catheter designed to support in a clinical setting?

  The Vertex Monitoring Catheter is specifically designed for use in cardiovascular procedures, particularly within cardiac catheterization labs. It facilitates real-time pressure and flow measurements in coronary or peripheral arteries, making it useful for both diagnostic assessments and interventional procedures where precise intravascular monitoring is required.

• Is the Vertex Monitoring Catheter intended for single-use or repeated use in a clinical environment?

  The Vertex Monitoring Catheter is explicitly intended for single-use only. It is supplied sterile and packaged for immediate use in controlled clinical settings, ensuring compliance with best practices for patient safety and infection control.

• How is the Vertex Monitoring Catheter supplied, and what does this mean for its readiness for use?

  The Vertex Monitoring Catheter is supplied sterile and pre-packaged for immediate use. This means it is ready to deploy directly from its packaging without requiring additional sterilization or preparation, streamlining workflow in the catheterization lab.

• Are there any specific storage requirements or restrictions mentioned for the Vertex Monitoring Catheter?

  The provided data does not specify detailed storage requirements, but since it is a single-use, sterile device, it should be stored in a clean, dry environment away from direct sunlight or extreme temperatures. Always follow manufacturer guidelines for optimal shelf life and sterility preservation.

• What regulatory pathway was followed for the Vertex Monitoring Catheter’s clearance, and what does this imply for its use?

  The Vertex Monitoring Catheter received FDA 510(k) clearance under the classification DXT (Injector and Syringe, Angiographic) with a decision of *Substantially Equivalent* (SESE). This means it was determined to be comparable to legally marketed devices in terms of safety and effectiveness, allowing it to be used in clinical settings as described in its labeling for intravascular monitoring and fluid delivery.