SCM CATH ( SIZES ARE VARYING BETWEEN 16G X 2'' AND 24G X 3/4'' ), MODEL 1.50, 1.77,1.88',2, 1.25, 1.50, 1.77,

• K Number: K071382
• Device Name: SCM CATH ( SIZES ARE VARYING BETWEEN 16G X 2'' AND 24G X 3/4'' ), MODEL 1.50, 1.77,1.88',2, 1.25, 1.50, 1.77,
• Manufacturer: SHIN CHANG MEDICAL CO., LTD.
• Date Cleared: 2007-10-16 ( 152 days)
• Product Code: FOZ
• Regulation Number: 880.5200
• Type: Traditional
• Panel: HO
• Reference & Predicate Devices: N/A

Intended Use

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.

Device Description

a device that consists of a slender tube and any necessary connecting fittings

AI/ML Overview

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves the device meets any such criteria. The document is a 510(k) clearance letter from the FDA for a device called "SCM CATH," and it primarily discusses regulatory classification and marketing authorization. There is no mention of specific device performance metrics, clinical studies, or data provenance.

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).