Edi Catheter ENFit— 510(k) K153688

Substantially Equivalent

Maquet Critical Care AB

FDA 510(k) clearance K153688 for Edi Catheter ENFit, Substantially Equivalent on 2017-03-02. Applicant: Maquet Critical Care AB.

Clearance details

Applicant: Maquet Critical Care AB
Product code: Code PIF
Advisory panel: Gastroenterology, Urology
Date received: 2015-12-23
Decision date: 2017-03-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Solna, SE

Download summary PDF View on FDA.gov ↗

Adverse events under product code PIF

product code PIF

Death: 13
Injury: 122
Other: 1
Total: 136

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.