Bardex Lubri-Sil I.C. Foley Catheter

Q: What is the product code of K984136?

The FDA product code is MJC – Catheter, Urological (Antimicrobial) And Accessories, a Class II (moderate risk) device regulated under 21 CFR 876.5130.

FDA 510(k) K984136 · Bard Medical Div.

Substantially Equivalent

510(k) numberK984136

Submission

Device name: Bardex Lubri-Sil I.C. Foley Catheter
Applicant: Bard Medical Div.
Covington, GA, US
Received: November 18, 1998
Decision date: February 16, 1999
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: MJC – Catheter, Urological (Antimicrobial) And Accessories
Device class: Class II (moderate risk)
Regulation: 21 CFR 876.5130
Specialty: Gastroenterology, Urology

Other 510(k)s with product code MJC

510(k)	Device	Applicant	Decision
K233094	Wellead® Latex Foley CatheterMJC · Traditional	Well Lead Medical (Hainan) Co., Ltd.	06/06/2024SE
K040658	Bardex I.C. Latex Foley CatheterMJC · Traditional	C.R. Bard, Inc.	09/29/2004SE
K033477	Hydrophilic-Antibacterial Intermittent Catheter, Intermittent Catheter Closed System KitMJC · Traditional	Rochester Medical Corp.	06/10/2004SE
K000251	Spectrum Silicone Foley CatheterMJC · Traditional	Cook Urological, Inc.	08/30/2000SE
K001143	Release NF Antibacterial Foley Catheter, Antibacterial Personal CatheterMJC · Traditional	Rochester Medical Corp.	07/07/2000SE
K993464	Bardex I.C. Pediatric Foley CatheterMJC · Abbreviated	C.R. Bard, Inc.	12/10/1999SE
K983101	Bardex I.C 4-WAY Foley Catheter Model 1865SIXX XX = 18,20,22,24MJC · Abbreviated	C.R. Bard, Inc.	11/03/1998SE
K971627	Silicone Antibacterial Foley CatheterMJC · Traditional	Rochester Medical Corp.	01/13/1998SE
K910318	Bard(R) Hydrogel/Silver-Coated Foley CatheterMJC · Traditional	C.R. Bard, Inc.	08/18/1994SE

More from C.R. Bard, Inc.

510(k)	Device	Decision
K984084	Bardex Lubri-Sil Foley CatheterEZL · Traditional	02/01/1999SE
K970110	Bard Flexible Endoscopy Injection System (651019)ODC · Traditional	02/19/1997SE

Questions and answers

When was Bardex Lubri-Sil I.C. Foley Catheter cleared by the FDA?

Bardex Lubri-Sil I.C. Foley Catheter (K984136) received a 510(k) decision of Substantially Equivalent on February 16, 1999, 90 days after the submission was received.

What is the product code of K984136?

The FDA product code is MJC – Catheter, Urological (Antimicrobial) And Accessories, a Class II (moderate risk) device regulated under 21 CFR 876.5130.