# K992532: Vantex Central Venous Catheter with Oligon Material with or Without Amc Thromboshield Coating

- Pathway: 510(k) (Traditional)
- Applicant: Baxter Healthcare Corp
- Decided: Jun 13, 2000 after 320 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: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 2 cite it directly.
0 of 4 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) Multi-Med Multi-Lumen Central Venous Catheter with AMC™ Thromboshield™: named in the summary without a submission number
- (no number) Arrow International’s Central Venous Multi-Lumen Catheter with ARROWgard Blue: named in the summary without a submission number

## Most influential descendants
- K061250: Multicath Expert (2006), 1 descendant of its own
- K113565: Multi-Med Central Venous Catheters (CVCS), with and Without Heparin Vantex Central Venous Catheters (CVCS), with Heparin (2012), 0 descendants of its own
- K072702: Stryker Antimic Catheter (2008), 0 descendants of its own

## Recalls of this device
- Nov 2, 2006 · Not classified · Z-0318-2007: Lack of Assurance of Sterility-Device packaging was manufactured with an incorrect lid that could compromise the sterility of the product.
- Oct 8, 2003 · Not classified · Z-0272-04: Lot is being recalled because some of the kits contain an incorrect guidewire.

## Indications for use
The Vantex™ Central Venous Catheter with OLIGON™ with or without AMC™ Thromboshield™ coating are indicated for use in patients requiring ptessure monitoring, infusion of solutions, and blood sampling in the central vein. All catheters are manufactured with a polyurcthane-based OLIGON™ antimicrobial polymer. The OLIGON™ material uses silver as the antimicrobial agent.

Source page: https://510kreport.com/device/K992532
Methodology: https://510kreport.com/methodology