Skip to content

Modified Perm-Cath

by Quinton, Inc. 510(k)

Active United States

510(k) K900835

Overview

The Modified Perm-Cath is a catheter, subclavian (product code LFJ), designed for long-term venous access. It is intended for insertion into the subclavian vein to facilitate repeated vascular access procedures, such as hemodialysis or chemotherapy administration. Constructed for durability, it is engineered to minimize complications associated with chronic catheter use, including thrombosis and infection.

This device is supplied as a single-use, sterile product and is regulated under FDA 510(k) clearance (K900835) as a Class II medical device under regulation 876.5540. It is intended for use in clinical settings where subclavian venous access is required, adhering to standard aseptic techniques. The Modified Perm-Cath is not MRI-safe, and proper storage conditions must be maintained to preserve sterility and functionality. No additional regulatory approvals beyond the stated 510(k) clearance are referenced in the available data.

AI-generated from registry data, 20 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK900835 Date9 May 1990ClearedStatusActive

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 6 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

Other devices from Quinton, Inc.

See all devices from Quinton, Inc. →

Questions

  • What clinical procedures is the Modified Perm-Cath primarily designed to support, and how does it help reduce complications?

    The Modified Perm-Cath is specifically designed for long-term venous access via the subclavian vein, making it ideal for repeated procedures like hemodialysis or chemotherapy administration. Its construction minimizes complications such as thrombosis and infection, which are common with chronic catheter use, by prioritizing durability and reliability in clinical settings.

  • Is the Modified Perm-Cath reusable, or is it intended for single-use only? How should it be stored to maintain its integrity?

    The Modified Perm-Cath is supplied as a single-use, sterile product. To preserve sterility and functionality, it must be stored under proper conditions as specified by the manufacturer, ensuring it remains uncontaminated until use.

  • Can this catheter be used in patients who require MRI scans, or are there any safety concerns related to imaging?

    The Modified Perm-Cath is explicitly not MRI-safe, meaning it should not be used in patients who require MRI imaging. Clinicians must ensure alternative access methods or MRI-compatible catheters are considered for such patients.

  • What regulatory pathway does the Modified Perm-Cath follow, and what does this mean for its use in clinical practice?

    The Modified Perm-Cath is regulated under FDA 510(k) clearance (K900835) as a Class II medical device, classified under product code LFJ (Subclavian Catheter). This clearance indicates it has been deemed substantially equivalent to a predicate device, allowing its use in clinical settings where subclavian venous access is required, provided standard aseptic techniques are followed.