28 results · 25ms · Sources: EU EUDAMED, US FDA

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PeritX™ 1L Drainage Kit (90-1010); PeritX™ 2L Drainage Kit (90-2010); PeritX™ Peritoneal Catheter Kit (50-9000C); PeritX™ Peritoneal Catheter and Starter Kit (50-9900C); PeritX™ Peritoneal Catheter Mini Kit (50-9050A); PleurX™ Low Profile Catheter Mini Kit (50-8050); Valve Cap (50-7235A); PeritX™ Valve Kit (50-7272); Catheter Access Kit (50-7280A); Lockable Drainage Line (50-7245A); Lockable Drainage Line Kit (50-7265A); PleurX™ Supplemental Insertion Kit (50-7262); Procedure Pack (50-

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

PERITX DRAINAGE BAG

FDA Adverse Event
Malfunction ·CAREFUSION, INC·Product code PNG·April 3, 2026

PERITX PERITONEAL CATHETER & STARTER KIT

FDA Adverse Event
Malfunction ·CAREFUSION, INC·Product code PNG·October 6, 2025

PERITX PERITONEAL CATHETER & STARTER KIT

FDA Adverse Event
Malfunction ·CAREFUSION, INC·Product code PNG·October 6, 2025

PERITX PERITONEAL CATHETER & STARTER KIT

FDA Adverse Event
Malfunction ·CAREFUSION, INC·Product code PNG·October 6, 2025

PERITX PERITONEAL CATHETER & STARTER KIT

FDA Adverse Event
Malfunction ·CAREFUSION, INC·Product code PNG·October 6, 2025

PERITX PERITONEAL CATHETER & STARTER KIT

FDA Adverse Event
Malfunction ·CAREFUSION, INC·Product code PNG·April 2, 2026

PLEURX DRAINAGE KIT 1000ML

FDA Adverse Event
Malfunction ·CAREFUSION, INC·Product code DWM·January 20, 2026

PERITX PERITONEAL CATHETER & STARTER KIT

FDA Adverse Event
Malfunction ·CAREFUSION, INC·Product code PNG·October 6, 2025

PERITX PERITONEAL CATHETER & STARTER KIT

FDA Adverse Event
Malfunction ·CAREFUSION, INC·Product code PNG·October 6, 2025

PLEURX DRAINAGE KIT 1000ML

FDA Adverse Event
Malfunction ·CAREFUSION, INC·Product code DWM·October 15, 2025

PERITX

FDA Adverse Event
Malfunction ·CAREFUSION, INC·Product code PNG·November 26, 2025

VALVE CAP

FDA Adverse Event
Malfunction ·CAREFUSION, INC·Product code DWM·November 5, 2025

PERITX PERITONEAL CATHETER & STARTER KIT

FDA Adverse Event
Malfunction ·CAREFUSION, INC·Product code PNG·October 6, 2025

PERITX

FDA Adverse Event
Malfunction ·CAREFUSION, INC·Product code PNG·October 29, 2025

PERITX DRAINAGE BAG KIT

FDA Adverse Event
Malfunction ·CAREFUSION, INC·Product code PNG·December 18, 2025

PLEURX DRAINAGE KIT 1000ML

FDA Adverse Event
Malfunction ·CAREFUSION, INC·Product code DWM·September 18, 2025

PERITX DRAINAGE BAG

FDA Adverse Event
Malfunction ·CAREFUSION, INC·Product code PNG·April 11, 2026

PERITX PERITONEAL CATHETER MINI KIT

FDA Adverse Event
Malfunction ·CAREFUSION, INC·Product code PNG·February 17, 2026

PLEURX LOCKABLE DRAINAGE LINE KIT

FDA Adverse Event
Injury ·CAREFUSION, INC·Product code DWM·January 5, 2026