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FDA 510(k)

Argyle 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 Extender

K-Number: K180485 · 2018-07-27

ApplicantCovidien, LLC
Decision Date2018-07-27
Product CodeFJS
Advisory CommitteeGU
DecisionUnknown

Device Summary

Argyle 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 Extender is the device name listed in this FDA 510(k) record. The listed applicant is Covidien, LLC. It received FDA 510(k) clearance on 2018-07-27 under 510(k) number K180485. The device is classified under product code FJS. It was reviewed by the GU advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the Argyle 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 Extender?

Argyle 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 Extender is a medical device that received FDA 510(k) clearance on 2018-07-27. The listed applicant is Covidien, LLC. The 510(k) number is K180485.

When did Argyle 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 Extender receive FDA 510(k) clearance?

Argyle 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 Extender received FDA 510(k) clearance on 2018-07-27, under 510(k) number K180485.

Who is the listed applicant for Argyle 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 Extender?

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

What is the FDA product code for Argyle 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 Extender?

The FDA product code for Argyle 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 Extender is FJS.

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.

NCT07641491Silver-Impregnated Dressings for Catheter Exit-Site and Tunnel Infections in Peritoneal Dialysis PatientsNOT_YET_RECRUITINGNCT07782762Effectiveness of the NowCath Foley in Reducing Catheter-Associated UTIs and Blockages in Long-Term Indwelling Catheter Users (REDUCE)RECRUITINGNCT05143164Hydrocolloid Dressing for Catheter Exit Site Care in Peritoneal Dialysis PatientsCOMPLETEDNCT07153939Pivotal Study of the Velocity™ pAVF SystemRECRUITING

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Related Devices (Code: FJS)

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.

K213602Argyle Peritoneal Dialysis Cathetor and Kit, Ritus Peritoneal Dialysis Catheter Tunneling Tool KitCovidien, 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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