Acute Peritoneal Dialysis Catheters

FDA 510(k) K854966 · Thermedics, Inc.

Substantially Equivalent

510(k) numberK854966

Submission

Device name
Acute Peritoneal Dialysis Catheters
Applicant
Thermedics, Inc.
Woburn, MA, US
Received
December 11, 1985
Decision date
January 9, 1986
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
FKO – Catheter, Peritoneal Dialysis, Single Use
Device class
Class II (moderate risk)
Regulation
21 CFR 876.5630
Specialty
Gastroenterology, Urology
Life-sustaining
Yes

Other 510(k)s with product code FKO

510(k)DeviceApplicantDecision
K964514Corpak Medsystems Cruz Catheter for Peritoneal DialysisFKO · Traditional Corpak, Inc.06/26/1998SE
K974570Peritoneal Dialysis Catheter ConnectorFKO · Traditional Medigroup, Inc.02/27/1998SE
K910787Titanium Connector (2 Part)FKO · Traditional Accurate Surgical Instruments Co.08/15/1991SE
K885037Amukin 50% - Airspray(R)FKO · Traditional Bernard J. Cooney, P.A.10/19/1990SE
K874650Peritoneal Dialysis Kit (Acute and Chronic Form)FKO · Traditional Quinton, Inc.12/09/1987SE
K872221Dialy-Nate Set & Dialy-Nate CatheterFKO · Traditional Gesco Intl., Inc.10/13/1987SE
K871730Modified Use of Pull-Apart Introducer SetFKO · Traditional Quinton, Inc.05/18/1987SE
K870472Acute Peritoneal Dialysis KitFKO · Traditional Quinton, Inc.02/25/1987SE
K860155Peritoneal Lavage Cath PLC-8,SET PLS-8, Kit PLK-8FKO · Traditional Medical Components, Inc.02/14/1986SESD
K845041Capd Staged ConnectorFKO · Traditional Abbott Laboratories02/21/1985SE

More from Abbott Laboratories

510(k)DeviceDecision
K894131Dermaport Vascular Access Device Model No. 50-1000DQY · Traditional 09/26/1989SE
K863128Peritoneal Dialysis CathetersFJS · Traditional 09/09/1986SE
K850076Wound Dressing Model ZB-6NAD · Traditional 04/15/1985SE

Questions and answers

When was Acute Peritoneal Dialysis Catheters cleared by the FDA?

Acute Peritoneal Dialysis Catheters (K854966) received a 510(k) decision of Substantially Equivalent on January 9, 1986, 29 days after the submission was received.

What is the product code of K854966?

The FDA product code is FKO – Catheter, Peritoneal Dialysis, Single Use, a Class II (moderate risk) device regulated under 21 CFR 876.5630.