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FDA 510(k)

PleurX Peritoneal Catheter System

K-Number: K160437 · 2016-11-03

ApplicantCare Fusion
Decision Date2016-11-03
Product CodePNG
Advisory CommitteeGU
DecisionUnknown

Device Summary

PleurX Peritoneal Catheter System is the device name listed in this FDA 510(k) record. The listed applicant is Care Fusion. It received FDA 510(k) clearance on 2016-11-03 under 510(k) number K160437. 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 2016-11-03. The listed applicant is Care Fusion. The 510(k) number is K160437.

When did PleurX Peritoneal Catheter System receive FDA 510(k) clearance?

PleurX Peritoneal Catheter System received FDA 510(k) clearance on 2016-11-03, under 510(k) number K160437.

Who is the listed applicant for PleurX Peritoneal Catheter System?

The FDA 510(k) record lists Care Fusion as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Care Fusion as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K233021BD SmartSite™ 13mm Vial Access Device; BD SmartSite™ 20mm Vial Access DeviceK231888BD Texium™ Needle-Free SyringeK221327BD Alaris™ Pump Infusion SetsK221319BD Alaris™ Pump Epidural Infusion SetK223101BD Secondary Infusion SetK223088BD SmartSite™ Needle-Free Connector

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Related Devices (Code: PNG)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K241278ASEPT® Glide Peritoneal Drainage SystemPfm Medical, Inc.K241946PeritX™ 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-Bard Peripheral Vascular, Inc.K230319Passio Pump Drainage SystemBearpac MedicalK221779ASEPT Peritoneal Drainage SystemPfm Medical, Inc.K212675Aspira Peritoneal Drainage SystemMerit Medical Systems, Inc.K201155PleurX Peritoneal Catheter SystemCare Fusion

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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