RELEASE NF ANTIBACTERIAL FOLEY CATHETER, ANTIBACTERIAL PERSONAL CATHETER

FDA 510(k) clearance K001143 · decided 2000-07-07

Clearance details

K-number: K001143
Device name: RELEASE NF ANTIBACTERIAL FOLEY CATHETER, ANTIBACTERIAL PERSONAL CATHETER
Applicant: Rochester Medical Corp.
Decision: Substantially Equivalent
Date received: 2000-04-10
Decision date: 2000-07-07
Days to decision: 88 days
Clearance type: Traditional
Product code: MJC
Device class: 2
Regulation number: 876.5130
Medical specialty: Gastroenterology, Urology
Advisory committee: Gastroenterology, Urology
Location: Stewartville, MN, US
Third-party review: No
Expedited review: No

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Devices cleared under the same product code - the starting set for predicate research.

Record	Firm	Date
Wellead® Latex Foley Catheter (K233094)	Well Lead Medical (Hainan) Co., Ltd.	2024-06-06
BARDEX I.C. LATEX FOLEY CATHETER (K040658)	C.R. Bard, Inc.	2004-09-29
HYDROPHILIC-ANTIBACTERIAL INTERMITTENT CATHETER, INTERMITTENT CATHETER CLOSED SYSTEM KIT (K033477)	Rochester Medical Corp.	2004-06-10
SPECTRUM SILICONE FOLEY CATHETER (K000251)	Cook Urological, Inc.	2000-08-30
BARDEX I.C. PEDIATRIC FOLEY CATHETER (K993464)	C.R. Bard, Inc.	1999-12-10
BARDEX LUBRI-SIL I.C. FOLEY CATHETER (K984136)	Bard Medical Div.	1999-02-16
BARDEX I.C 4-WAY FOLEY CATHETER MODEL 1865SIXX XX = 18,20,22,24 (K983101)	C.R. Bard, Inc.	1998-11-03
SILICONE ANTIBACTERIAL FOLEY CATHETER (K971627)	Rochester Medical Corp.	1998-01-13
BARD(R) HYDROGEL/SILVER-COATED FOLEY CATHETER (K910318)	C.R. Bard, Inc.	1994-08-18

No recalls on record reference this clearance.