# K071382: 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,

- Pathway: 510(k) (Traditional)
- Applicant: Shinchang Medical Co., Ltd.
- Decided: Oct 16, 2007 after 152 days
- Product code: FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days)
- Device class: 2
- Regulation: 21 CFR 880.5200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for 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.

Source page: https://510kreport.com/device/K071382
Methodology: https://510kreport.com/methodology