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Found 9 results
510(k) Data Aggregation
K Number
K233094Device Name
Wellead® Latex Foley Catheter
Manufacturer
Well Lead Medical (Hainan) Co., Ltd.
Date Cleared
2024-06-06
(254 days)
Product Code
MJC, EYB, EZL
Regulation Number
876.5130Why did this record match?
Product Code :
MJC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Latex Foley Catheter is inserted into the bladder through urethra and are indicated for routine urine drainage or for routine post-operative drainage and bladder irrigation.
Device Description
The Latex Foley Catheter is inserted through the urethra during urinary catheterization and goes into the bladder for urine drainage or irrigation. It consists of a shaft, a drainage funnel, an inflation funnel, an irrigation funnel (if present), a balloon and a valve. The device is made from latex with silicone coating and available in different types (e.g., straight, Tiemann, female etc.) and sizes for adult and pediatric use.
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K Number
K040658Device Name
BARDEX I.C. LATEX FOLEY CATHETER
Manufacturer
C.R. BARD, INC.
Date Cleared
2004-09-29
(201 days)
Product Code
MJC
Regulation Number
876.5130Why did this record match?
Product Code :
MJC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Bardex® I.C. latex Foley catheter is indicated for use in the drainage and/or collection, the The Dardes .. Online. Generally, drainage is accomplished by inserting the catheter through the urethra and into the bladder. However, drainage is sometimes calleter through the "drethra" and "into" the "bladen" "Hower, such as nephrostomy tract.
Device Description
The Bard® Bardex® I.C. latex Foley catheter is a two-way Foley catheter which is placed in the bladder through the urethra. The balloon on the distal end of the catheter is inflated with sterile water after insertion and used to secure the catheter in place and ensure that the opening in the distal tip of the catheter is positioned correctly to allow for urine drainage. The urine drains out through the catheter into a collection device attached to the catheter.
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K Number
K033477Device Name
HYDROPHILIC-ANTIBACTERIAL INTERMITTENT CATHETER, INTERMITTENT CATHETER CLOSED SYSTEM KIT
Manufacturer
ROCHESTER MEDICAL CORP.
Date Cleared
2004-06-10
(220 days)
Product Code
MJC
Regulation Number
876.5130Why did this record match?
Product Code :
MJC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Hydrophilic-Antibacterial Intermittent Catheter is intended for urological use only. The Hydrophilic-Antibacterial Intermittent Catheter is intended for urinary bladder drainage in the management of incontinence, neurogenic bladder dysfunction, and surgical procedures in adult males and females requiring catheterization. Efficacy of the Hydrophilic-Antibacterial Intermittent Catheter in preventing urinary tract infection during intermittent use has not been shown. It is not intended as a treatment for active urinary tract infection.
Intermittent Catheter Closed System Kit is intended for use by patients for the purpose of bladder drainage.
Device Description
The Hydrophilic-Antibacterial Intermittent Catheter consists of a hydrophilic and antibacterial coated single lumen catheter with either two or four drainage eyes on the proximal tip. It is constructed from medical grade elastomers.
The Intermittent Catheter Closed System Kit consists of a single lumen urethral catheter (Hydrophilic-Antibacterial Intermittent Catheter, Hydrophilic Personal® Catheter K000723, or Antibacterial Personal® Catheter K001143) in a closed system-in-a-bag configuration with an introducer tip and insertion supplies.
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K Number
K000251Device Name
SPECTRUM SILICONE FOLEY CATHETER
Manufacturer
COOK UROLOGICAL, INC.
Date Cleared
2000-08-30
(216 days)
Product Code
MJC
Regulation Number
876.5130Why did this record match?
Product Code :
MJC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K001143Device Name
RELEASE NF ANTIBACTERIAL FOLEY CATHETER, ANTIBACTERIAL PERSONAL CATHETER
Manufacturer
ROCHESTER MEDICAL CORP.
Date Cleared
2000-07-07
(88 days)
Product Code
MJC
Regulation Number
876.5130Why did this record match?
Product Code :
MJC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K993464Device Name
BARDEX I.C. PEDIATRIC FOLEY CATHETER
Manufacturer
C.R. BARD, INC.
Date Cleared
1999-12-10
(58 days)
Product Code
MJC
Regulation Number
876.5130Why did this record match?
Product Code :
MJC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Bardex I. C. Pediatric Foley Catheter is intended for use in the drainage and/or collection and/or measurement of urine. Generally, drainage is accomplished by inserting the catheter through the urethra and into the bladder. However, drainage is sometimes accomplished by suprapubic or other placement of the catheter, such as a nephrostomy tract.
Device Description
The Bardex I. C. Pediatric Foley Catheter is a two-way latex Foley catheter with silver and hydrogel coatings.
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K Number
K984136Device Name
BARDEX LUBRI-SIL I.C. FOLEY CATHETER
Manufacturer
BARD MEDICAL DIV.
Date Cleared
1999-02-16
(90 days)
Product Code
MJC
Regulation Number
876.5130Why did this record match?
Product Code :
MJC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Bardex® Lubri-Sil™ I.C. Foley Catheter is indicated for use in the drainage and/or collection and/or measurement of urine. Generally, drainage is accomplished by inserting the catheter through the urethra and into the bladder. However, drainage is sometimes accomplished by suprapubic or other placement of the catheter, such as a nephrostomy tract.
Some Foley catheters, especially those with larger (30cc) balloons are used to assist in hemostasis following surgery such as transurethral resection of the prostate.
Device Description
The Bardex® Lubri-Sil™ I.C. Foley Catheter is a two-way all-silicone Foley catheter with silver and lubricious hydrophilic coatings.
The Bard Lubri-Sil I. C. Foley Catheter is constructed of high grade extruded clear silicone rubber with a molded tip and funnel. It is a twolumen catheter with a drainage lumen and an inflation lumen with two-way valve. A silver coating and then a hydrophilic polymeric coating are applied to the finished catheter. The hydrophilic coating becomes very slippery when wet. The silver coating discourages bacterial adhesion to the catheter surface. The Lubri-Sil I.C. Foley Catheter is available in even shaft sizes 12-24 Fr. with a 5cc balloon and in even shaft sizes 16-24 Fr. with a 30cc balloon.
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K Number
K983101Device Name
BARDEX I.C 4-WAY FOLEY CATHETER MODEL 1865SIXX XX = 18,20,22,24
Manufacturer
C.R. BARD, INC.
Date Cleared
1998-11-03
(61 days)
Product Code
MJC
Regulation Number
876.5130Why did this record match?
Product Code :
MJC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Bardex I. C. 4-Way Foley Catheter is indicated for use in bladder/urinary tract drainage/irrigation and to assist in hemostasis and surgical site drainage following procedures such as transurethral resection of the prostate.
Device Description
The Bardex I. C. 4-Way Foley Catheter is a new catheter design incorporating the addition of a fourth lumen for prostatic drainage and the addition of several prostatic drainage eyes proximal to the balloon.
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K Number
K971627Device Name
SILICONE ANTIBACTERIAL FOLEY CATHETER
Manufacturer
ROCHESTER MEDICAL CORP.
Date Cleared
1998-01-13
(256 days)
Product Code
MJC
Regulation Number
876.5130Why did this record match?
Product Code :
MJC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Silicone Antibacterial Foley Catheter is intended for short term use to provide continuous urinary bladder drainage in adult males and females requiring catheterization for surgical procedures, monitoring uring output, management of incontinence, and voiding dysfunction. The catheter has been shown to provide a statistically significant redution in the incidence of catheter acquired bacterial urinary tract infection during the first 5 days of catheterization. This device is not intended to be used as a treatment for active urinary tract infection.
Device Description
The catherer consists of a standard configuration Foley catheter with a drainage lumen that exits through two drainage eyes on the proximal end. A retention balloon is located near the proximal catheter tip. The retention balloon is filled thru a second lumen with a Luer valve that extends from a side arm on the distal end of the catherer to the balloon. The catherer is coated with nitrofurazone impregnated siliconc on the outside surface and inner lumen. It is available in 12, 18 and 20 Fr sizes. All French sizes are provided in a 16 inch length with a 5 or 10 cc size balloon.
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