ENTERALITE INFINITY SPIKE ENTERAL DELIVERY SET; ENTERALITE INFINITY 500 ML BAG ENTERAL DELIVERY SET;— 510(k) K131154

Substantially Equivalent

Zevex, Inc.

FDA 510(k) clearance K131154 for ENTERALITE INFINITY SPIKE ENTERAL DELIVERY SET; ENTERALITE INFINITY 500 ML BAG ENTERAL DELIVERY SET;, Substantially Equivalent on 2014-02-12. Applicant: Zevex, Inc..

Clearance details

Applicant: Zevex, Inc.
Product code: Code LZH
Advisory panel: General Hospital
Date received: 2013-04-24
Decision date: 2014-02-12
Decision: Substantially Equivalent
Clearance type: Special
Location: Salt Lake City, UT, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code LZH

product code LZH

Death: 12
Malfunction: 4,186
Total: 4,198

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.