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Mar Cor Services Bicarb System

by Mar Cor Services, Inc.

510(k) K003560

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 NumberK003560 Date8 Jun 2001ClearedStatusActive

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  • Withdrawn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
FIN
Device Class
Class II
Regulation
21 CFR Part 876.5820
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 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 Mar Cor Services Bicarbonate System is a tank-based device designed for the preparation and delivery of bicarbonate solutions in dialysis applications. It is classified as a Class II medical device under regulation number 876.5820 and is intended for use in gastroenterology and urology settings.

The system received FDA 510(k) clearance (K003560) on June 8, 2001, as substantially equivalent to a predicate device. It is manufactured by Mar Cor Services, Inc. in Harleysville, Pennsylvania, and is supplied as a non-sterile, reusable system for mixing and distributing bicarbonate solution to points of use in dialysis facilities.

Other devices from Mar Cor Services, Inc.