Flex-Neck PD Catheter

FDA 510(k) K970159 · Janin Group, Inc.

Substantially Equivalent

510(k) numberK970159

Submission

Device name
Flex-Neck PD Catheter
Applicant
Janin Group, Inc.
Aurora, IL, US
Received
January 16, 1997
Decision date
September 5, 1997
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

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
K012502Medigroup Catheter Extender/Repair KitFJS · Traditional 02/04/2002SE
K013017Medigroup Key TubeFJS · Traditional 12/06/2001SE
K991042Ash Advantage Peritoneal CatheterFJS · Traditional 06/25/1999SE
K810512Mediseal Camera CoversKQM · Traditional 03/13/1981SE

Questions and answers

When was Flex-Neck PD Catheter cleared by the FDA?

Flex-Neck PD Catheter (K970159) received a 510(k) decision of Substantially Equivalent on September 5, 1997, 232 days after the submission was received.

What is the product code of K970159?

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