Atlas FDA

BARDEX LUBRI-SIL I.C. FOLEY CATHETER

FDA 510(k) clearance K984136 · decided 1999-02-16

Clearance details

K-number
K984136
Device name
BARDEX LUBRI-SIL I.C. FOLEY CATHETER
Applicant
Bard Medical Div.
Decision
Substantially Equivalent
Date received
1998-11-18
Decision date
1999-02-16
Days to decision
90 days
Clearance type
Traditional
Product code
MJC
Device class
2
Regulation number
876.5130
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
Location
Covington, GA, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

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

RecordFirmDate
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
RELEASE NF ANTIBACTERIAL FOLEY CATHETER, ANTIBACTERIAL PERSONAL CATHETER (K001143)Rochester Medical Corp.2000-07-07
BARDEX I.C. PEDIATRIC FOLEY CATHETER (K993464)C.R. Bard, Inc.1999-12-10
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

Recalls involving this device

RecordFirmDate
Bardex Foley Catheter, 22 Fr 40cc- 20cc Ribbed Balloons, Coleman Model Red Latex, 3 Way Ra recall (Z-1144-03)C.R. Bard, Inc., Urological Division2003-08-21