Lifemed Lifecoil Catheters

FDA 510(k) K841929 · Lifemed of California

Substantially Equivalent

510(k) numberK841929

Submission

Device name
Lifemed Lifecoil Catheters
Applicant
Lifemed of California
Walker, MI, US
Received
May 10, 1984
Decision date
August 8, 1984
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
FKX – System, Peritoneal, Automatic Delivery
Device class
Class II (moderate risk)
Regulation
21 CFR 876.5630
Specialty
Gastroenterology, Urology
Life-sustaining
Yes

Other 510(k)s with product code FKX

510(k)DeviceApplicantDecision
K250523Archimedes Pro Automated Peritoneal Dialysis Cycler (3014-00000-1); Archimedes Standard…FKX · Traditional Simergent, LLC10/02/2025SE
K243371Byonyks X-1 APD Cycler; Byonyks Automated PD Set DS-1FKX · Traditional Byonyks Pvt, Ltd.05/16/2025SE
K220935Digital Dialysis Clinic - Intelligent Dialysis Assistant (IDA) with Medical Supervision…FKX · Traditional Iren-Medical, Ltd.12/29/2022SE
K222318Fresenius Liberty Select CyclerFKX · Traditional Fresenius Medical Care Renal Therapies Group, LLC10/31/2022SE
K212522Lilliput APD SystemFKX · Traditional Fresenius Medical Care Renal Therapies Group, LLC04/15/2022SE
K212658CloudCath Peritoneal Dialysis Drain Set Monitoring SystemFKX · Traditional Cloudcath02/09/2022SE
K201867Homechoice Claria APD System, Sharesource Connectivity Platform for Use with the…FKX · Traditional Baxter Healthcare Corporation11/19/2020SE
K181108Fresenius Liberty Select CyclerFKX · Special Fresenius Medical Care Renal Therapies Group, LLC05/24/2018SE
K173718Liberty Cycler SetFKX · Traditional Fresenius Medical Care Renal Therapies Group, LLC05/01/2018SE
K171652Fresenius Liberty Select CyclerFKX · Traditional Fresenius Medical Care Renal Therapies Group, LLC09/15/2017SE

More from Fresenius Medical Care Renal Therapies Group, LLC

510(k)DeviceDecision
K001329Intravascular IV Set, IV Set with Burette, Extension SetFPA · Traditional 02/14/2001SE
K903502Lifecoil CatheterFJS · Traditional 10/22/1990SE
K821624Low Volume Infustion SetFPA · Traditional 06/22/1982SE

Questions and answers

When was Lifemed Lifecoil Catheters cleared by the FDA?

Lifemed Lifecoil Catheters (K841929) received a 510(k) decision of Substantially Equivalent on August 8, 1984, 90 days after the submission was received.

What is the product code of K841929?

The FDA product code is FKX – System, Peritoneal, Automatic Delivery, a Class II (moderate risk) device regulated under 21 CFR 876.5630.