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Mahurkar Subclavian Catheter

by Quinton, Inc. 510(k)

Active United States

510(k) K821400

Overview

The Mahurkar Subclavian Catheter is a central venous catheter designed for insertion into the subclavian vein. It is classified under the product code LFJ and falls under the category of subclavian catheters, intended for establishing reliable venous access. This device is engineered to facilitate procedures requiring long-term or repeated vascular access, such as hemodialysis.

The catheter is supplied as a single-use medical device and is regulated under FDA 510(k) clearance (K821400), with a classification as Class II under special controls. It is intended for use in clinical settings where sterile conditions are maintained, such as hospitals or dialysis centers. The device adheres to regulatory standards for central venous catheters and is authorized for use in the United States.

AI-generated from registry data, 1 Oct 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK821400 Date23 Jun 1982ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 5 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
LFJ
Device Class
Class II
Regulation
21 CFR Part 876.5540
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the Mahurkar Subclavian Catheter used for?

    The Mahurkar Subclavian Catheter is designed for establishing reliable venous access in clinical settings where long-term or repeated vascular procedures are required. This includes applications such as hemodialysis, where consistent and stable access to the venous system is critical for patient treatment.

  • Is the Mahurkar Subclavian Catheter intended for single-use or reuse?

    The Mahurkar Subclavian Catheter is supplied as a single-use medical device. This design ensures patient safety by preventing cross-contamination and maintaining sterility between uses, which is essential in clinical environments like hospitals and dialysis centers.

  • What regulatory approval does the Mahurkar Subclavian Catheter hold?

    The Mahurkar Subclavian Catheter is authorized for use in the United States under FDA 510(k) clearance (K821400). It is classified as a Class II device under special controls, adhering to regulatory standards for central venous catheters and ensuring its safety and effectiveness for intended clinical use.

  • In which clinical settings is the Mahurkar Subclavian Catheter intended for use?

    This catheter is intended for use in sterile clinical settings such as hospitals and dialysis centers. Its design supports procedures requiring long-term or repeated vascular access, where maintaining sterile conditions is paramount to patient safety and procedural success.

  • What distinguishes the Mahurkar Subclavian Catheter from other subclavian catheters?

    The Mahurkar Subclavian Catheter is specifically engineered for reliable venous access in procedures like hemodialysis, where stability and durability are essential. Its FDA-cleared status and classification under product code LFJ further differentiate it as a regulated, single-use device tailored for clinical environments requiring long-term access solutions.