MAR COR COMPLETE WATER TREATMENT SYSTEM FOR KDNEY DIALYSIS

K945559 · Mar Cor Services, Inc. · FIP · May 28, 1996 · Gastroenterology, Urology

Device Facts

• Record ID: K945559
• Device Name: MAR COR COMPLETE WATER TREATMENT SYSTEM FOR KDNEY DIALYSIS
• Applicant: Mar Cor Services, Inc.
• Product Code: FIP · Gastroenterology, Urology
• Decision Date: May 28, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5665
• Device Class: Class 2

Intended Use

The Complete Water Treatment System for Kidney Dialysis is intended to treat water from an incoming supply for use in kidney dialysis, carrying the treated water to the point where it enters individual kidney machines.

Device Story

Water treatment system for kidney dialysis; processes incoming water supply through multiple components; delivers treated water to individual dialysis machines. Used in clinical dialysis settings; operated by trained medical staff. System ensures water quality meets requirements for dialysis procedures; supports patient safety by removing contaminants from source water.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Water treatment system consisting of multiple filtration/purification components. System architecture designed for continuous water processing from source to dialysis machine interface. No specific materials or software algorithms described.

Indications for Use

Indicated for use in clinical settings to provide treated water for kidney dialysis machines.

Regulatory Classification

Identification

A water purification system for hemodialysis is a device that is intended for use with a hemodialysis system and that is intended to remove organic and inorganic substances and microbial contaminants from water used to dilute dialysate concentrate to form dialysate. This generic type of device may include a water softener, sediment filter, carbon filter, and water distillation system.

Special Controls

*Classification.* Class II (special controls). The device, when it is a water purification subsystem disinfectant, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.

Predicate Devices

• Water Pure RO System (K873487)
• C.D. Medical, Inc., Drake Willock RO Water Treatment System (K894106)

Submission Summary (Full Text)

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IAR COR
RIVICES, INC.
MAY 28 1995 K945559

# SUMMARY

Mar Cor Services, Inc., has developed a complete water treatment system for kidney dialysis. This system is equivalent to such other commercial water treatment systems as the Water Pure RO System (K# 873487) and the C.D. Medical, Inc., Drake Willock RO Water Treatment System (K# 894106), and other comparable water treatment systems.

Mar Cor Services, Inc., is confident that this water treatment system is comparable to existing water treatment systems for kidney dialysis, providing a system that, from the incoming water supply, treats the water through a number of system components and carries it to the point where it enters the individual kidney machines.

Through this 510(k) notification, Mar Cor Services, Inc., requests that it's Complete Water Treatment System for Kidney Dialysis be granted substantial equivalence to other water treatment systems currently on the market.

364 MAPLE AVENUE
HARLEYSVILLE, PA 19438
215-256-9585
FAX-256-4551
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