# K991541: A-Med Vascular Cannula, Models V24-10-08, V24-10-16, V24-10-32, V24-21-08, V24-21-44

- Pathway: 510(k) (Traditional)
- Applicant: A-Med Systems, Inc.
- Decided: Dec 28, 1999 after 239 days
- Product code: DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4210
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K831769 (1983). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K891576: Fem-Flex Femoral Access Cannulation Set, Research Medical, Inc. (1989) Summary page 1.
- K974259: Venous Flex II Peripheral and Intra-Operative Access Venous Return Cannulae, Edwards Lifesciences Research Medical (1998) Summary page 1.

## Indications for use
The A-Med Vascular Cannula is intended for intraoperative access to the arterial (i.e., aorta, femoral artery or pulmonary artery) or venous system, (i.e., femoral vein, right atrium) during procedures requiring arterial or venous access for short term extracorporeal support (less than six hours). Arterial or venous access is left to the discretion of the physician.

Source page: https://510kreport.com/device/K991541
Methodology: https://510kreport.com/methodology