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FDA 510(k)

Argyle Peritoneal Dialysis Cathetor and Kit, Ritus Peritoneal Dialysis Catheter Tunneling Tool Kit

K-Number: K213602 · 2022-01-14

ApplicantCovidien, LLC
Decision Date2022-01-14
Product CodeFJS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Argyle Peritoneal Dialysis Cathetor and Kit, Ritus Peritoneal Dialysis Catheter Tunneling Tool Kit is a medical device manufactured by Covidien, LLC. It received FDA 510(k) clearance on 2022-01-14 under approval number K213602. The device is classified under product code FJS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Argyle Peritoneal Dialysis Cathetor and Kit, Ritus Peritoneal Dialysis Catheter Tunneling Tool Kit?

Argyle Peritoneal Dialysis Cathetor and Kit, Ritus Peritoneal Dialysis Catheter Tunneling Tool Kit is a medical device that received FDA 510(k) clearance on 2022-01-14. It is manufactured by Covidien, LLC. The 510(k) number is K213602.

When was Argyle Peritoneal Dialysis Cathetor and Kit, Ritus Peritoneal Dialysis Catheter Tunneling Tool Kit approved by the FDA?

Argyle Peritoneal Dialysis Cathetor and Kit, Ritus Peritoneal Dialysis Catheter Tunneling Tool Kit received FDA 510(k) clearance on 2022-01-14, under approval number K213602.

What company makes Argyle Peritoneal Dialysis Cathetor and Kit, Ritus Peritoneal Dialysis Catheter Tunneling Tool Kit?

Argyle Peritoneal Dialysis Cathetor and Kit, Ritus Peritoneal Dialysis Catheter Tunneling Tool Kit is manufactured by Covidien, LLC.

What is the FDA product code for Argyle Peritoneal Dialysis Cathetor and Kit, Ritus Peritoneal Dialysis Catheter Tunneling Tool Kit?

The FDA product code for Argyle Peritoneal Dialysis Cathetor and Kit, Ritus Peritoneal Dialysis Catheter Tunneling Tool Kit is FJS.

Related Clinical Trials

NCT07612124 Evaluation of the Application of Intelligent Applications in Patients Undergoing Peritoneal Dialysis COMPLETED NCT05143164 Hydrocolloid Dressing for Catheter Exit Site Care in Peritoneal Dialysis Patients COMPLETED NCT07179705 Using a Hypotension Prediction Index to Prevent Low Blood Pressure During Dialysis in ICU Patients RECRUITING NCT04034251 Intraperitoneal and Intravenous Paclitaxel Chemotherapy With Oral Capecitabine for Gastric Adenocarcinoma With Peritoneal Carcinomatosis TERMINATED

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Related Devices (Code: FJS)

K180485Argyle Peritoneal Dialysis Catheter and Kits, Argyle Presternal Peritoneal Dialysis Catheter and Kits, Argyle Peritoneal Dialysis Accessory Two Part Titanium Luer Adapter, Argyle Adult Peritoneal Dialysis Accessory Titanium Catheter ExtenderCovidien, LLC

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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