# K113565: Multi-Med Central Venous Catheters (CVCS), with and Without Heparin Vantex Central Venous Catheters (CVCS), with Heparin

- Pathway: 510(k) (Special)
- Applicant: Edwards Lifesciences, LLC
- Decided: May 18, 2012 after 168 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: 10 generations back to K001901 (2000). 32 ancestors in all.
No later device cites it as a predicate yet.
5 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K955839: Multi-Med Multi-Lumen Central Venous Catheter, Baxter Edwards (1996) Summary page 1.
- K992532: Vantex Central Venous Catheter with Oligon Material with or Without Amc Thromboshield Coating, Baxter Healthcare Corp (2000) Summary page 1.
- K091709: Multi-Med Central Venous Catheters, Models: M3720HKIC, M4820HKIC, Edwards Lifesciences, LLC (2009) Summary page 1.
- K100739: Volumeview System, Models VLV520FT6R, VLV520FT8R, VLV520FT6R5, Edwards Lifesciences, LLC (2010) Summary page 1.
- K110167: Presep Oligon Oximetry Catheters (16 CM, W/Heparin), (20CM, W/Heparin), Edwards Lifesciences, LLC (2011) Summary page 1.

## Indications for use
The Multi-Med catheters are indicated for use in patients requiring administration of solutions, blood sampling, central venous pressure monitoring and injection of contrast media. The Vantex central venous catheters are indicated for use in patients requiring administration of solutions, blood sampling, central venous pressure monitoring and injection of contrast media. All catheters include a soft tip to reduce the risk of vessel perforation.

Source page: https://510kreport.com/device/K113565
Methodology: https://510kreport.com/methodology