# K022257: Vomed Peripheral Vascular Accessories, Models 1010 XXX-7090 XXX & 9006 XXX-9011 XXX

- Pathway: 510(k) (Traditional)
- Applicant: Vomed Volzer Medizintechnik GmbH & Co.
- Decided: Oct 4, 2002 after 84 days
- Product code: DRC (Trocar)
- Device class: 2
- Regulation: 21 CFR 870.1390
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
VOMED trocars are intended to provide access to the thoracic cavity through ports in the intercostal spaces, with minimal to no rib retraction. VOMED trocars and trocar sleeves then allow ehdoscopic instruments, thoracoscopes, laparoscopes, a tube or a channel, and accessory devices to be inserted and used during cardiac surgery procedures. VOMED adapters, tube connectors, caps and plugs, stopcocks and valves are non-invasive, reusable devices for use in cardiovascular applications to interconnect tubing and other devices during extracorporeal bypass procedures, effectively establishing a conduit between the devices for the flow of blood and other extracorporeal fluids.

Source page: https://510kreport.com/device/K022257
Methodology: https://510kreport.com/methodology