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Continuous Arteriovenous Hemofiltration Catheter 10 Fr

by Medron, Inc.

510(k) K971897

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 NumberK971897 Date21 Oct 1997ClearedStatusActive

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  • Withdrawn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)

Full name
Continuous Arteriovenous Hemofiltration Catheter 10 Fr (Cavh)
510(k) Number
FDA Product Code
LFK
Device Class
Class II
Regulation
21 CFR Part 876.5540
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 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 Continuous Arteriovenous Hemofiltration Catheter is a femoral catheter designed to provide vascular access for continuous arteriovenous hemofiltration. It is inserted into the femoral artery to utilize the patient's natural arterial pressure to drive blood flow through an external hemofilter, facilitating the removal of water, electrolytes, and small molecular substances from the blood without the need for an external blood pump.

This device is identified by K-number K971897 and is regulated under 21 CFR 876.5540 as an FDA class 2 medical device. It has received FDA 510(k) clearance as a substantially equivalent device. The catheter is supplied in a 10 Fr size for clinical use.

Other devices from Medron, LLC

Questions

AI-generated answers, 23 Sep 2026

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

  • What is the primary function of the Medron CAVH catheter?

    This 10 Fr catheter is designed for femoral artery insertion to provide vascular access for continuous arteriovenous hemofiltration. It allows for the removal of water, electrolytes, and small molecular substances from the blood.

  • Does this catheter require an external blood pump for operation?

    No, this device is specifically designed to utilize the patient's natural arterial pressure to drive blood flow through an external hemofilter, eliminating the need for an external blood pump during the procedure.

  • What is the regulatory status of this hemofiltration catheter?

    The Medron Continuous Arteriovenous Hemofiltration Catheter has received FDA 510(k) clearance under K-number K971897. It is classified as an FDA class 2 medical device under 21 CFR 876.5540.