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Baxter APD 12' Extension Line

by Baxter Healthcare Corp

510(k) K925403

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

Source FDA 510(k), synced 6 Oct 2026.

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK925403 Date22 Feb 1994ClearedStatusActive

Official records

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  • Withdrawn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
KDJ
Device class
Class II
Regulation
21 CFR Part 876.5630
Advisory committee
Gastroenterology, Urology
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 Sep 2026

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

This device is a set for peritoneal dialysis administration, specifically designed as a disposable extension line for use with automated peritoneal dialysis cycler tubing sets. It features an Easy-Lock connector and is intended to extend the patient line in peritoneal dialysis systems.

It is supplied as a disposable, non-sterile device for use in clinical settings such as hospitals and physician's offices. The device is regulated under FDA 510(k) clearance K925403, with product code KDJ and regulation number 876.5630, and is classified as a Class II medical device for gastroenterology and urology applications.

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