510(k) K142539— EnteraLite Infinity Enteral Pump Delivery Set, 1200 mL Enteral Feeding Delivery Set

Substantially Equivalent

Zevex, Inc.

Clearance details

Applicant: Zevex, Inc.
Product code: Code PIF
Advisory panel: Gastroenterology, Urology
Date received: 2014-09-09
Decision date: 2015-01-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Salt Lake City, UT, 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.