Biologic 1000 Hemodialysis MACH/HD-1000 Disp Cartr

FDA 510(k) K864179 · Ash Medical Systems, Inc.

Substantially Equivalent

510(k) numberK864179

Submission

Device name
Biologic 1000 Hemodialysis MACH/HD-1000 Disp Cartr
Applicant
Ash Medical Systems, Inc.
West Lafayette, IN, US
Received
October 24, 1986
Decision date
December 11, 1986
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
FKT – System, Dialysate Delivery, Sorbent Regenerated
Device class
Class II (moderate risk)
Regulation
21 CFR 876.5600
Specialty
Gastroenterology, Urology
Life-sustaining
Yes

Other 510(k)s with product code FKT

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K1238352008 Hemodialysis Sorbent SystemFKT · Special Renal Solutions, Inc.02/15/2013SE
K0933622008 Hemodialysis Sorbent SystemFKT · Abbreviated Renal Solutions, Inc.08/13/2010SE
K070739Allient Sorbent Hemodialysis System, Model# 1500FKT · Special Renal Solutions, Inc.05/25/2007SE
K060381Allient Sorbet Hemodialysis System, Model 1100FKT · Special Renal Solutions, Inc.05/24/2006SE
K043574Allient Sorbent Hemodialysis System, Model 1000FKT · Traditional Renal Solutions, Inc.06/03/2005SE
K031099Sorb+Hisorb+CartridgeFKT · Traditional Renal Solutions, Inc.09/17/2003SE
K954623Redy 2000 System (Therapeutic Plasma Exchange Option and Monitoring Line Y-Connector)FKT · Traditional Gambro Healthcare08/28/1996SE
K882428Redy 2000FKT · Traditional Organon Teknika Corp.10/25/1988SE
K874137Modified Biologic 1000 Hemodial. & HD-1000 Dis CarFKT · Traditional Ash Medical Systems, Inc.04/08/1988SE
K870270Modified Bio. Hemodialysis & HD-1000 Disp. Cart.FKT · Traditional Ash Medical Systems, Inc.02/25/1987SE

More from Ash Medical Systems, Inc.

510(k)DeviceDecision
K874137Modified Biologic 1000 Hemodial. & HD-1000 Dis CarFKT · Traditional 04/08/1988SE
K870270Modified Bio. Hemodialysis & HD-1000 Disp. Cart.FKT · Traditional 02/25/1987SE

Questions and answers

When was Biologic 1000 Hemodialysis MACH/HD-1000 Disp Cartr cleared by the FDA?

Biologic 1000 Hemodialysis MACH/HD-1000 Disp Cartr (K864179) received a 510(k) decision of Substantially Equivalent on December 11, 1986, 48 days after the submission was received.

What is the product code of K864179?

The FDA product code is FKT – System, Dialysate Delivery, Sorbent Regenerated, a Class II (moderate risk) device regulated under 21 CFR 876.5600.