510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K150084Substantially Equivalent

Argyle¿ Polyvinyl Chloride (PVC) and Kangaroo¿ Polyurethane (PU) Neonatal and Pediatric Feeding Tubes with ENFit connector

Medtronic, Inc., Mansfield MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K150084 is the FDA 510(k) clearance record for Argyle¿ Polyvinyl Chloride (PVC) and Kangaroo¿ Polyurethane (PU) Neonatal and Pediatric Feeding Tubes with ENFit connector, a class II device, cleared for Covidien on under FDA product code PIF (Gastrointestinal Tubes With Enteral Specific Connectors). FDA's definition for product code PIF reads: "To facilitate enteral specific connections". FDA records list 1,525 510(k) clearances for Medtronic, Inc., from to . As of , FDA records show no recalls naming K150084.

Clearance record

Decision date
Received
(179 days to decision)
Product code
PIF Gastrointestinal Tubes With Enteral Specific Connectors
Regulation
21 CFR 876.5980
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Covidien 15 Hampshire St., Mansfield MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PIF

Trailing 12 months
3 clearances under product code PIF in the twelve months to October 2026, March 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code PIF, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20261
April 20260
May 20260
June 20260
July 20260
August 20261
September 20261
October 20260