# K120839: Novacath Secure IV Catheter System-18G

- Pathway: 510(k) (Traditional)
- Applicant: Tangent Medical Technologies, Inc.
- Decided: Jul 20, 2012 after 122 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: 1 generation back to K971339 (1997). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032843: Nexiva Closed IV Catheter System, Becton Dickinson Infusion Therapy Systems, Inc. (2004) Summary page 1.
- K971339: Insyte, Insyte-W, Insyte Autoguard Catheters, Becton Dickinson Vascular Access, Inc. (1997) Summary page 1.
- K051355: Vanishpoint I.V. Catheter, Retractable Technologies, Inc. (2005) Summary page 1.

## Most influential descendants
- K160374: 20G x 1.25 NovaCath Secure IV Catheter System, 24G x 0.56 NovaCath Secure IV Catheter System (2016), 0 descendants of its own

## Indications for use
The NovaCath TM 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 NovaCathTM may be utilized in any patient population with consideration given to vascular anatomy and appropriateness of procedure. The 18, 20 and 22 Gauge NovaCathTM devices are suitable for use with power injectors for up to a maximum of 300 psi.

Source page: https://510kreport.com/device/K120839
Methodology: https://510kreport.com/methodology