# K160374: 20G x 1.25 NovaCath Secure IV Catheter System, 24G x 0.56 NovaCath Secure IV Catheter System

- Pathway: 510(k) (Special)
- Applicant: Tangent Medical Technologies, Inc.
- Decided: Mar 11, 2016 after 30 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
Longest line of descent: 2 generations back to K971339 (1997). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120839: Novacath Secure IV Catheter System-18G, Tangent Medical Technologies, Inc. (2012) Summary page 4.

## Indications for use
The NovaCath™ Secure IV Catheter System 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 intravascularly. The needle-shielding feature aids in the prevention of needlestick injuries. Upon catheter insertion, blood is contained within the device to aid in the prevention of blood exposure. The NovaCath™ device may be utilized in any patient population with consideration given to vascular anatomy and appropriateness of procedure. The 18, 20, and 22 gauge NovaCath™ devices are suitable for use with power injectors for a maximum of 300psi.

Source page: https://510kreport.com/device/K160374
Methodology: https://510kreport.com/methodology