Lifecoil Catheter

FDA 510(k) K903502 · Lifemed of California

Substantially Equivalent

510(k) numberK903502

Submission

Device name
Lifecoil Catheter
Applicant
Lifemed of California
Compton, CA, US
Received
August 3, 1990
Decision date
October 22, 1990
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
FJS – Catheter, Peritoneal, Long-Term Indwelling
Device class
Class II (moderate risk)
Regulation
21 CFR 876.5630
Specialty
Gastroenterology, Urology
Implant
Yes

Other 510(k)s with product code FJS

510(k)DeviceApplicantDecision
K213602Argyle Peritoneal Dialysis Cathetor and Kit, Ritus Peritoneal Dialysis Catheter…FJS · Traditional Covidien, LLC01/14/2022SE
K180485Argyle Peritoneal Dialysis Catheter and Kits, Argyle Presternal Peritoneal Dialysis…FJS · Traditional Covidien, LLC07/27/2018SESK
K130441Faller StyletFJS · Traditional Medionics International, Inc.04/19/2013SE
K121383PS X Series (Basic Components and Catheter), PD X Series (Catheter with All Components)FJS · Traditional Medical Components, Inc.09/05/2012SESK
K120130Faller TrocarFJS · Traditional Medigroup, Inc.05/21/2012SE
K113354Veta Peritoneal Dialysis CatheterFJS · Traditional Pfm Medical, Inc.03/13/2012SESK
K071167Flex-Neck Exxtended Peritoneal Dialysis Catheter and Accessories, Model CF-5560FJS · Traditional Medigroup, Inc.08/31/2007SESK
K070730Flex-Neck Arc CatheterFJS · Traditional Medigroup, Inc.07/03/2007SESK
K060897Embedding Tool, Model TE-1000FJS · Traditional Medigroup, Inc.07/18/2006SE
K053123PD CathFJS · Traditional Med-Conduit, Inc.03/29/2006SE

More from Med-Conduit, Inc.

510(k)DeviceDecision
K001329Intravascular IV Set, IV Set with Burette, Extension SetFPA · Traditional 02/14/2001SE
K841929Lifemed Lifecoil CathetersFKX · Traditional 08/08/1984SE
K821624Low Volume Infustion SetFPA · Traditional 06/22/1982SE

Questions and answers

When was Lifecoil Catheter cleared by the FDA?

Lifecoil Catheter (K903502) received a 510(k) decision of Substantially Equivalent on October 22, 1990, 80 days after the submission was received.

What is the product code of K903502?

The FDA product code is FJS – Catheter, Peritoneal, Long-Term Indwelling, a Class II (moderate risk) device regulated under 21 CFR 876.5630.