EnteraLite Infinity Enteral Pump Delivery Set, 1200 mL Enteral Feeding Delivery Set— 510(k) K142539
Substantially EquivalentZevex, Inc.
FDA 510(k) clearance K142539 for EnteraLite Infinity Enteral Pump Delivery Set, 1200 mL Enteral Feeding Delivery Set, Substantially Equivalent on 2015-01-08. Applicant: Zevex, Inc.. Device class: 2.
Clearance details
- Applicant
- Zevex, Inc.
- Product code
- Code PIF
- Device class
- Class 2
- Regulation
- 21 CFR 876.5980
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Salt Lake City, UT, US
Recent devices under product code PIF
view allMore clearances from Zevex, Inc.
view all- K242660 — Curlin 8000 Ambulatory Infusion System; Enterprise Solution (ES) Software; Curlin 380-series Administration Sets
- K232793 — Curlin 8000 Ambulatory Infusion System; Enterprise Solution (ES) Software; Curlin 380-Series Adminstration Sets
- K131154 — ENTERALITE INFINITY SPIKE ENTERAL DELIVERY SET; ENTERALITE INFINITY 500 ML BAG ENTERAL DELIVERY SET
- K012147 — DEVICE MODIFICATION OF ENTERAL FEEDING SETS FOR GRAVITY AND PUMP USE
Adverse events under product code PIF
product code PIF- Death
- 13
- Injury
- 122
- Other
- 1
- Total
- 136
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K142539
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K142539.
Data sourced from openFDA. This site is unofficial and independent of the FDA.