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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 a medical device manufactured by Pfm Medical, Inc.. It received FDA 510(k) clearance on 2023-05-02 under approval 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. It is manufactured by Pfm Medical, Inc.. The 510(k) number is K221779.

When was ASEPT Peritoneal Drainage System approved by the FDA?

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

What company makes ASEPT Peritoneal Drainage System?

ASEPT Peritoneal Drainage System is manufactured by Pfm Medical, Inc..

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

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

Related Clinical Trials

NCT07603531 Assessment of the Efficacy of the Dynamic Decongestive System in the Maintenance Phase of Lower Limb Lymphedema NOT_YET_RECRUITING NCT06201429 A Multi-center, Early Feasibility Study of Using the Mechanical Tissue Resuscitation™ (MTR®) Therapy System for Removal of Excess Fluid in Subjects Who Have Had a Portion of Their Skull Removed to Expose the Dura/Brain and Require Drainage for Fluid Removal. RECRUITING NCT07494812 Examining the Feasibility of Using Pressure Gradient Regulated Automated Cerebral Spinal Fluid Drainage During External Lumbar Drain Trials NOT_YET_RECRUITING NCT07527702 Low (-4) vs Physiologic (-8) Pressure Digital Continuous Suction After Lung Resection RECRUITING NCT07253662 Pressurized Intraperitoneal Aerosolized Chemotherapy (PIPAC) in Patients With Peritoneal Metastasis From Pancreatic Adenocarcinoma RECRUITING NCT05511987 Digital Chest Tube Drainage System (Thopaz+) Versus Analog in Pediatric Patients RECRUITING

Other Devices by Pfm Medical, Inc.

K173114primeMidline Catheters K192802primeMidline Catheters K201137Asept Surgical Face Mask K213666NuCath Wedge Pressure Catheter K242763JetCan® Pro Safety Huber Needle K241278ASEPT® Glide Peritoneal Drainage System

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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 K201155PleurX Peritoneal Catheter SystemCare Fusion K212675Aspira Peritoneal Drainage SystemMerit Medical Systems, Inc. K230319Passio Pump Drainage SystemBearpac Medical

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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