HEPARIN IV FLUSH SYRINGE, 10 U/ML \

• K Number: K990390
• Device Name: HEPARIN IV FLUSH SYRINGE, 10 U/ML \
• Manufacturer: ROCAP DIV. OF SABRATEK CORP.
• Date Cleared: 1999-12-10 ( 304 days)
• Product Code: FOZ
• Regulation Number: 880.5200
• Type: Traditional
• Panel: General Hospital
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

The ROCAP Heparin Flush Syringe 10 U/mL is indicated for use to maintain patency of indwelling venous access devices.

Device Description

Heparin Flush Syringe, 10 U/mL

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a Heparin IV Flush Syringe. It confirms that the device is substantially equivalent to legally marketed predicate devices.

However, this document does not contain any information regarding acceptance criteria or a study that proves the device meets acceptance criteria. The letter only states that the device is substantially equivalent, allowing it to be marketed. There are no details about performance metrics, study designs, sample sizes, ground truth establishment, or expert involvement as requested in the prompt.

Therefore, I cannot provide the requested information from the provided text.

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).