510(k) K142539 ยท PIF Gastrointestinal Tubes With Enteral Specific Connectors
EnteraLite Infinity Enteral Pump Delivery Set, 1200 mL Enteral Feeding Delivery Set
| Applicant | Zevex, Inc., Salt Lake City UT, US |
| Decision | Substantially Equivalent, Jan 8, 2015 |
| Received | Sep 9, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K142539
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 20, 2015 | MOOG Medical Devices Group Catalog No. INF0020-A EnteraLite Infinity Enteral Pump Delivery Set with ENFit Connector System and Transitional Stepped Connector (spiked set); Catalog No. INF0500-A - 500ml EnteraLite Infinity Ente Terminated |
PIF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.