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FDA 510(k)

PleurX Peritoneal Catheter System

K-Number: K201155 · 2020-10-21

ApplicantCare Fusion
Decision Date2020-10-21
Product CodePNG
Advisory CommitteeGU
DecisionUnknown

Device Summary

PleurX Peritoneal Catheter System is a medical device manufactured by Care Fusion. It received FDA 510(k) clearance on 2020-10-21 under approval number K201155. The device is classified under product code PNG. It was reviewed by the GU advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the PleurX Peritoneal Catheter System?

PleurX Peritoneal Catheter System is a medical device that received FDA 510(k) clearance on 2020-10-21. It is manufactured by Care Fusion. The 510(k) number is K201155.

When was PleurX Peritoneal Catheter System approved by the FDA?

PleurX Peritoneal Catheter System received FDA 510(k) clearance on 2020-10-21, under approval number K201155.

What company makes PleurX Peritoneal Catheter System?

PleurX Peritoneal Catheter System is manufactured by Care Fusion.

What is the FDA product code for PleurX Peritoneal Catheter System?

The FDA product code for PleurX Peritoneal Catheter System is PNG.

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Related Devices (Code: PNG)

K162457Rocket Indwelling Peritoneal Catheter (IPC) Insertion KitRocket Medical Plc K160437PleurX Peritoneal Catheter SystemCare Fusion K152105Rocket IPC Insertion Set, Rocket IPC Mini Insertion SetRocket Medical Plc K212675Aspira Peritoneal Drainage SystemMerit Medical Systems, Inc. K230319Passio Pump Drainage SystemBearpac Medical K221779ASEPT Peritoneal Drainage SystemPfm Medical, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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