K142539 is an FDA 510(k) clearance for the EnteraLite Infinity Enteral Pump Delivery Set, 1200 mL Enteral Feeding Delivery Set. This device is classified as a Gastrointestinal Tubes With Enteral Specific Connectors (Class II - Special Controls, product code PIF).
Submitted by Zevex, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on January 8, 2015, 121 days after receiving the submission on September 9, 2014.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5980. To Facilitate Enteral Specific Connections..
| 510(k) Number | K142539 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 09, 2014 |
| Decision Date | January 08, 2015 |
| Days to Decision | 121 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | PIF - Gastrointestinal Tubes With Enteral Specific Connectors |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5980 |
| Definition | To Facilitate Enteral Specific Connections. |