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FDA 510(k)

ASEPT Peritoneal Drainage System

K-Number: K221779 · 2023-05-02

ApplicantPfm Medical, Inc.
Decision Date2023-05-02
Product CodePNG
Advisory CommitteeGU
DecisionUnknown

Device Summary

ASEPT Peritoneal Drainage System is the device name listed in this FDA 510(k) record. The listed applicant is Pfm Medical, Inc.. It received FDA 510(k) clearance on 2023-05-02 under 510(k) number K221779. 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 ASEPT Peritoneal Drainage System?

ASEPT Peritoneal Drainage System is a medical device that received FDA 510(k) clearance on 2023-05-02. The listed applicant is Pfm Medical, Inc.. The 510(k) number is K221779.

When did ASEPT Peritoneal Drainage System receive FDA 510(k) clearance?

ASEPT Peritoneal Drainage System received FDA 510(k) clearance on 2023-05-02, under 510(k) number K221779.

Who is the listed applicant for ASEPT Peritoneal Drainage System?

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

What is the FDA product code for ASEPT Peritoneal Drainage System?

The FDA product code for ASEPT Peritoneal Drainage System is PNG.

Other records listing Pfm Medical, Inc. 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.

K242763JetCan® Pro Safety Huber NeedleK241278ASEPT® Glide Peritoneal Drainage SystemPMA P120009OCCLUDER, PATENT DUCTUS, ARTERIOSUSK213666NuCath Wedge Pressure CatheterK201137Asept Surgical Face MaskK192802primeMidline Catheters

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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 MedicalK212675Aspira Peritoneal Drainage SystemMerit Medical Systems, Inc.K201155PleurX Peritoneal Catheter SystemCare FusionK162457Rocket Indwelling Peritoneal Catheter (IPC) Insertion KitRocket Medical Plc

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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