Anivia SG1000 Pump Console— 510(k) K221491

Substantially Equivalent

Apmtd, Inc.

FDA 510(k) clearance K221491 for Anivia SG1000 Pump Console, Substantially Equivalent on 2023-02-03. Applicant: Apmtd, Inc..

Clearance details

Applicant: Apmtd, Inc.
Product code: Code DWA
Advisory panel: Cardiovascular
Date received: 2022-05-23
Decision date: 2023-02-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wilmington, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DWA

product code DWA

Death: 15
Malfunction: 1,654
Total: 1,669

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.