Extracorporeal's Exp 400 Parallel Plate

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K802364 ↗

FDA Product Code

FJG

Device Class

Class II

Regulation

21 CFR Part 876.5820

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Male Luer Connector & Hinged Cap

  Class II

  FDA 510(k) K820169 Active Cleared 5 Feb 1982

• Parallel Plate Dialyzer Holder

  Class II

  FDA 510(k) K811292 Active Cleared 2 Jun 1981

• Tracheostomy Tubes, Short and Long Term

  Class II

  FDA 510(k) K791044 Active Cleared 13 Jun 1979

• Ultrafiltration Controller

  Class II

  FDA 510(k) K832547 Active Cleared 3 Jan 1984

• Extracorporeals' Alternate Membrane

  Class II

  FDA 510(k) K801344 Active Cleared 21 Jul 1980

• Intersept* Venous Reservoir Bag & Holder

  Class II

  FDA 510(k) K803059 Active Cleared 22 Dec 1980

See all devices from Extracorporeal Medical Specialities, Inc. →

• What is the EXP 400 Parallel Plate Dialyzer used for?

  The EXP 400 Parallel Plate is a dialyzer with parallel flow design intended for extracorporeal blood processing procedures in gastroenterology and urology medical specialties.

• How is the EXP 400 Parallel Plate supplied?

  The device is supplied by Extracorporeal Medical Specialties, Inc. and is available as a single-use device for extracorporeal blood processing procedures.

• What is the regulatory status of the EXP 400 Parallel Plate?

  The EXP 400 Parallel Plate received FDA 510(k) clearance with number K802364 on January 29, 1981, as substantially equivalent. It is regulated under product code FJG and regulation number 876.5820.

• What sizes and models are available for the EXP 400 Parallel Plate?

  The device is available as the EXP 400 Parallel Plate model, with specific size details not provided in the available data. For complete specifications, please consult the manufacturer's documentation.