CLEAR OR BRAIDED CONTRAST MEDIA INJECTION LINE OR WITHOUT ROTATOR, CATH LAB KIT

• K Number: K024126
• Device Name: CLEAR OR BRAIDED CONTRAST MEDIA INJECTION LINE OR WITHOUT ROTATOR, CATH LAB KIT
• Manufacturer: ABBOTT LABORATORIES
• Date Cleared: 2003-01-14 ( 29 days)
• Product Code: DQO
• Regulation Number: 870.1200
• Type: Special
• Panel: CV
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

Indicated as 10" (or up to 48") CLEAR (or BRAIDED) CONTRAST MEDIA INJECTION LINE WITH ROTATOR, for use in Cardiac catheterization and radiology special procedure

Device Description

High Pressure Tubing (intravascular administration set)

AI/ML Overview

This document is a 510(k) premarket notification letter from the FDA to Abbott Laboratories for a device named "High Pressure Tubing." The letter states that the device is substantially equivalent to legally marketed predicate devices.

However, the provided document does not contain any information about acceptance criteria, device performance testing, study details (sample size, data provenance, ground truth establishment, expert qualifications, adjudication methods), or comparative effectiveness studies (MRMC or standalone).

Therefore, I cannot answer your request based on the provided text. The document is solely an FDA clearance letter and does not include the technical details of the device's validation or testing.

Regulation Number and Section

§ 870.1200 Diagnostic intravascular catheter.

(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).