# K012128: Protectiv Acuvance IV Catheter System

- Pathway: 510(k) (Traditional)
- Applicant: Ethicon Endo-Surgery, Inc.
- Decided: Aug 1, 2001 after 23 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: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
8 later devices descend from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) PROTECTIV* ACUVANCE IV Catheter System: named in the summary without a submission number

## Most influential descendants
- K140504: Accucath BC Intravascular Catheter System (2014), 7 descendants of its own
- K153298: AccuCath Intravascular Catheter (2015), 5 descendants of its own
- K162894: AccuCath Intravascular Catheter (2016), 4 descendants of its own
- K243105: Ruby Intravascular Catheter (2025), 1 descendant of its own
- K260432: Ruby Intravascular Catheter (2026), 0 descendants of its own

## Recalls of this device
- Nov 21, 2016 · Class II · Z-0789-2017: Smiths Medical became aware that three (3) lots of Acuvance2 Safety Catheter, product number 1720-AI, contain devices with missing or incorrectly positioned side port valves.

## Indications for use
A properly placed LV. catheter provides access to a vein or artery. The LV. Catheter System is designed for single use and has a needlestick protection feature. The risk of accidental needlesticks is reduced by a self-blunting needle system activated automatically as the catheter is threaded into the vessel. These catheters may be used for any patient population with consideration given to patient size, appropriateness for the solution being infused, and duration of therapy. 14 to 22 gauge catheters may be used with power injectors up to 300 psi.

Source page: https://510kreport.com/device/K012128
Methodology: https://510kreport.com/methodology