# K820883: Septisleeve

- Pathway: 510(k) (Traditional)
- Applicant: Argon Medical Corp.
- Decided: Apr 29, 1982 after 30 days
- Product code: DYG (Catheter, Flow Directed)
- Device class: 2
- Regulation: 21 CFR 870.1240
- 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.
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 has not posted a summary or statement for it, so its predicates are not known.

## Recalls of this device
- Oct 16, 2018 · Class II · Z-0295-2020: The seal formed on the edge of the pouch may be incomplete, which could result in a loss of sterility to the product.

Source page: https://510kreport.com/device/K820883
Methodology: https://510kreport.com/methodology