Ecomed Disposable Angiographic Syringes— 510(k) K162088

Substantially Equivalent

Ecomed Solutions, LLC

FDA 510(k) clearance K162088 for Ecomed Disposable Angiographic Syringes, Substantially Equivalent on 2017-01-27. Applicant: Ecomed Solutions, LLC.

Clearance details

Applicant: Ecomed Solutions, LLC
Product code: Code DXT
Advisory panel: Cardiovascular
Date received: 2016-07-28
Decision date: 2017-01-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mundelein, IL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DXT

product code DXT

Death: 39
Injury: 242
Malfunction: 463
Other: 3
Total: 747

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.