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Flexxicon Plus Dual Lumen Dialysis Catheter

by Vas-Cath, Inc.

510(k) K895506

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK895506 Date9 Feb 1990ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

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

Overview

AI-generated summary, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Flexxicon Plus Dual Lumen Dialysis Catheter is a Class II medical device designed for dialysis procedures. It features a dual lumen configuration for efficient dialysis treatment.

This catheter is supplied as a single-use device and is not MRI compatible. It is regulated under product code LFJ with FDA 510(k) clearance K895506, granted on February 9, 1990, as substantially equivalent.

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