510(k) K200082— BD Univia RightFit Enteral Extension Sets and Transitional Adapters

Substantially Equivalent

Mps Medical, Inc.

Clearance details

Applicant: Mps Medical, Inc.
Product code: Code PIF
Advisory panel: Gastroenterology, Urology
Date received: 2020-01-15
Decision date: 2020-07-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brea, CA, US

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.