APPALEAD GW+03XXXXXXR SERIES— 510(k) K003394

Substantially Equivalent

Nipro Medical Corp.

FDA 510(k) clearance K003394 for APPALEAD GW+03XXXXXXR SERIES, Substantially Equivalent on 2001-01-30. Applicant: Nipro Medical Corp..

Clearance details

Applicant: Nipro Medical Corp.
Product code: Code DQX
Advisory panel: Cardiovascular
Date received: 2000-11-01
Decision date: 2001-01-30
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Miami, FL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DQX

product code DQX

Death: 298
Injury: 4,385
Malfunction: 7,203
Other: 5
Total: 11,891

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.