FEMOSTOP II DISPOSABLE SET, FEMOSTOP II COMPRESSION ARCH, FEMOSTOP II PUMP, FEMOSTOP II BILATERAL ADAPTER— 510(k) K980898

Substantially Equivalent

Radi Medical Systems AB

FDA 510(k) clearance K980898 for FEMOSTOP II DISPOSABLE SET, FEMOSTOP II COMPRESSION ARCH, FEMOSTOP II PUMP, FEMOSTOP II BILATERAL ADAPTER, Substantially Equivalent on 1998-04-21. Applicant: Radi Medical Systems AB.

Clearance details

Applicant: Radi Medical Systems AB
Product code: Code DXC
Advisory panel: Cardiovascular
Date received: 1998-03-09
Decision date: 1998-04-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Uppsala, SE

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Adverse events under product code DXC

product code DXC

Death: 14
Injury: 442
Malfunction: 2,209
Other: 1
Total: 2,666

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.