TK Pre-Filled Normal Saline Flush Syringe

• K Number: K230756
• Device Name: TK Pre-Filled Normal Saline Flush Syringe
• Manufacturer: Anhui Tiankang Medical Technology Co., Ltd.
• Date Cleared: 2023-08-12 ( 145 days)
• Product Code: NGT
• Regulation Number: 880.5200
• Type: Traditional
• Panel: HO
• Reference & Predicate Devices: N/A

Intended Use

The Pre-Filled Normal Saline Flush Syringe is intended to be used only for the flushing vascular access devices.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain information about acceptance criteria or a study proving that a device meets those criteria. The document is an FDA 510(k) clearance letter for a medical device called "TK Pre-Filled Normal Saline Flush Syringe."

The letter acknowledges the submission of a premarket notification and states that the device is substantially equivalent to legally marketed predicate devices. It also outlines regulatory requirements but does not include details about performance testing, study designs, sample sizes, ground truth establishment, or expert qualifications.

Therefore, I cannot generate the requested table and information based on the given input.

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).