Skip to content

Duo-Flow Side x Side Double Lumen Catheter

by Medical Components, Inc. (dba MedComp)

510(k) K192807

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK192807 Date23 Apr 2020ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 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  • Withdrawn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
MPB
Device Class
Class II
Regulation
21 CFR Part 876.5540
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 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 Duo-Flow Side x Side Double Lumen Catheter is a non-implanted hemodialysis catheter designed for short-term central venous access. It is indicated for use in hemodialysis, apheresis, and infusion procedures.

This device is constructed from polyurethane and features a tapered tip design with an internal coaxial lumen configuration. It is available in various French sizes including 9F, 11.5F, and 14F, with straight or pre-curved configurations. The device has received FDA 510(k) clearance.

Other devices from Medical Components, Inc. (dba MedComp)

See all devices from Medical Components, Inc. (dba MedComp) →