FDA 510(k)

PLEURX PERITONEAL CATHETER KIT AND PLEURX DRAINAGE KITS

K-Number: K051711 · 2005-11-15

Decision Date2005-11-15

Product CodePNG

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

PLEURX PERITONEAL CATHETER KIT AND PLEURX DRAINAGE KITS is the device name listed in this FDA 510(k) record. The listed applicant is Denver Biomedical, Inc.. It received FDA 510(k) clearance on 2005-11-15 under 510(k) number K051711. The device is classified under product code PNG. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PLEURX PERITONEAL CATHETER KIT AND PLEURX DRAINAGE KITS?

PLEURX PERITONEAL CATHETER KIT AND PLEURX DRAINAGE KITS is a medical device that received FDA 510(k) clearance on 2005-11-15. The listed applicant is Denver Biomedical, Inc.. The 510(k) number is K051711.

When did PLEURX PERITONEAL CATHETER KIT AND PLEURX DRAINAGE KITS receive FDA 510(k) clearance?

PLEURX PERITONEAL CATHETER KIT AND PLEURX DRAINAGE KITS received FDA 510(k) clearance on 2005-11-15, under 510(k) number K051711.

Who is the listed applicant for PLEURX PERITONEAL CATHETER KIT AND PLEURX DRAINAGE KITS?

The FDA 510(k) record lists Denver Biomedical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PLEURX PERITONEAL CATHETER KIT AND PLEURX DRAINAGE KITS?

The FDA product code for PLEURX PERITONEAL CATHETER KIT AND PLEURX DRAINAGE KITS is PNG.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Denver Biomedical, Inc. as applicant

K052436PLEURX PLEURAL CATHETER KIT, MODEL 50-7000 K012235DENVER PLEURAL EFFUSION SHUNT AND DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBER K011862DENVER ASCITES SHUNT AND PERCUTANEOUS ACCESS KIT WITH ASCITIES SHUNT K011831MODIFICATION TO PLEURX PLEURAL CATHETER AND DRAINAGE KITS

Related Devices (Code: PNG)

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 Medical K221779ASEPT Peritoneal Drainage SystemPfm Medical, Inc.K212675Aspira Peritoneal Drainage SystemMerit Medical Systems, Inc.K201155PleurX Peritoneal Catheter SystemCare Fusion

Official Source

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