Imed Technology Intravascular Administration Set, Imed Technology Extension Set— 510(k) K150513

Substantially Equivalent

Imed Technology, Inc.

FDA 510(k) clearance K150513 for Imed Technology Intravascular Administration Set, Imed Technology Extension Set, Substantially Equivalent on 2015-05-28. Applicant: Imed Technology, Inc..

Clearance details

Applicant: Imed Technology, Inc.
Product code: Code FPA
Advisory panel: General Hospital
Date received: 2015-02-27
Decision date: 2015-05-28
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Carrollton, TX, US

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Adverse events under product code FPA

product code FPA

Death: 95
Injury: 14,421
Malfunction: 125,815
Other: 30
Total: 140,361

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.