Pleurx Peritoneal Catheter System

Q: What is the product code of K113854?

The FDA product code is PNG – Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling, a Class II (moderate risk) device regulated under 21 CFR 876.5630.

FDA 510(k) K113854 · Care Fusion

Unknown

510(k) numberK113854

Submission

Device name: Pleurx Peritoneal Catheter System
Applicant: Care Fusion
Waukegan, IL, US
Received: December 29, 2011
Decision date: March 19, 2012
Decision: Unknown (SESK)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: PNG – Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling
Device class: Class II (moderate risk)
Regulation: 21 CFR 876.5630
Specialty: Gastroenterology, Urology
Implant: Yes
Life-sustaining: Yes

For drainage of refractory ascites with long-term occurrence from the peritoneal cavity.

Other 510(k)s with product code PNG

510(k)	Device	Applicant	Decision
K241278	ASEPT® Glide Peritoneal Drainage SystemPNG · Traditional	Pfm Medical, Inc.	01/14/2025SE
K241946	PeritX 1L Drainage Kit (90-1010); PeritX 2L Drainage Kit (90-2010); PeritX Peritoneal…PNG · Traditional	Bard Peripheral Vascular, Inc.	12/06/2024SE
K230319	Passio Pump Drainage SystemPNG · Traditional	Bearpac Medical	11/24/2023SESK
K221779	ASEPT Peritoneal Drainage SystemPNG · Traditional	Pfm Medical, Inc.	05/02/2023SESK
K212675	Aspira Peritoneal Drainage SystemPNG · Special	Merit Medical Systems, Inc.	12/14/2021SESK
K201155	PleurX Peritoneal Catheter SystemPNG · Traditional	Care Fusion	10/21/2020SESK
K162457	Rocket Indwelling Peritoneal Catheter (IPC) Insertion KitPNG · Traditional	Rocket Medical Plc	11/14/2016SEKD
K160437	PleurX Peritoneal Catheter SystemPNG · Traditional	Care Fusion	11/03/2016SEKD
K152105	Rocket IPC Insertion Set, Rocket IPC Mini Insertion SetPNG · Traditional	Rocket Medical Plc	03/29/2016SESK
K122422	Pleurx Pleural Catheter System Pleurx Catheter Access Kit Pleurx Slide Valved Peelable…PNG · Traditional	Care Fusion	10/24/2012SESK

More from Care Fusion

510(k)	Device	Decision
K233021	BD SmartSite 13mm Vial Access Device; BD SmartSite 20mm Vial Access DeviceLHI · Traditional	03/06/2024SE
K231888	BD Texium Needle-Free SyringeFMF · Traditional	09/25/2023SE
K221327	BD Alaris Pump Infusion SetsFPA · Traditional	07/21/2023SE
K221319	BD Alaris Pump Epidural Infusion SetPWH · Traditional	07/21/2023SE
K223101	BD Secondary Infusion SetFPA · Traditional	05/12/2023SE
K223088	BD SmartSite Needle-Free ConnectorFPA · Traditional	04/07/2023SE
K223076	BD Texium Closed Male LuerONB · Traditional	03/24/2023SE
K201155	PleurX Peritoneal Catheter SystemPNG · Traditional	10/21/2020SESK
K170405	BD Curve Ascites ShuntKPM · Traditional	11/02/2017SESK
K171531	Jamshidi Bone Marrow Biopsy/Aspiration Needle, Jamshidi T-Handle Bone Marrow…KNW · Traditional	09/11/2017SE

Questions and answers

When was Pleurx Peritoneal Catheter System cleared by the FDA?

Pleurx Peritoneal Catheter System (K113854) received a 510(k) decision of Unknown on March 19, 2012, 81 days after the submission was received.

What is the product code of K113854?

The FDA product code is PNG – Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling, a Class II (moderate risk) device regulated under 21 CFR 876.5630.