NUOVOCATH

• K Number: K083454
• Device Name: NUOVOCATH
• Manufacturer: U.S. SAFETY SYRINGES CO., INC.
• Date Cleared: 2008-12-04 ( 13 days)
• Product Code: FOZ
• Regulation Number: 880.5200
• Type: Traditional
• Panel: HO
• Reference & Predicate Devices: N/A

Intended Use

The NUOVOcath IV Catheter in size 14G to 26 G is used for venous access for the infusion of I.V. fluids, medicines into the circulating system.

Device Description

NUOVOCATH IV CATHETER

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a medical device called "NUOVOCath IV Catheter." It is not a study report and therefore does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth methodologies.

The letter confirms that the device is "substantially equivalent" to legally marketed predicate devices, which means it has been cleared for market based on its similarity to existing devices, not necessarily based on new performance studies described in detail within this document.

Therefore, I cannot extract the requested information from this text. The document's purpose is regulatory clearance, not a scientific publication detailing a performance study.

Regulation Number and Section

§ 880.5200 Intravascular catheter.

(a)
Identification. An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.(b)
Classification. Class II (performance standards).