# K980898: Femostop II Disposable Set, Femostop II Compression Arch, Femostop II Pump, Femostop II Bilateral Adapter

- Pathway: 510(k) (Traditional)
- Applicant: Radi Medical Systems AB
- Decided: Apr 21, 1998 after 43 days
- Product code: DXC (Clamp, Vascular)
- Device class: 2
- Regulation: 21 CFR 870.4450
- 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. The FDA summary names its predicate without a number.
- (no number) FemoStop®II System with FemoStop®II Disposable Set, FemoStop®II Compression Arch and FemoStop®II Pump: named in the summary without a submission number

## Indications for use
The FemoStop®II™" System is indicated in the compression of the femoral artery or vein after catheterization.

Source page: https://510kreport.com/device/K980898
Methodology: https://510kreport.com/methodology