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510(k) Data Aggregation
K Number
K013921Device Name
PORGES SILICONE DOUBLE LOOP URETERAL STENT, MODEL # AJ4X / BJ1X / BJ2X
Manufacturer
PORGES S.A.
Date Cleared
2002-10-17
(324 days)
Product Code
FAD
Regulation Number
876.4620Why did this record match?
Applicant Name (Manufacturer) :
PORGES S.A.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Standard versions: Drainage of the upper urinary tract over fistulas or ureteral obstructions (e.g. periureteral tumour), Cicatrisation stent. Reinforced versions: Management of ureteral stenoses, Partial enlargement of the diameter: localised stenoses connected with ureteropelvic junction syndrome, Total enlargement of the diameter: stenoses over all or part of the ureter.
Device Description
The PORGES™ Silicone double loop ureteral stents are supplied in kits, containing the following components: A double loop ureteral stent and an obturator, A guide-wire, where applicable, A pusher (where applicable supplied with a clamp). The catheter is manufactured entirely from silicone elastomer. The ureteral stents are made of the same yellow silicone tubing as the predicate silicone ureteral stent. They are steerable or non-steerable, and radiopaque. Most references are available in 06/07/08 CH/Fr and in different lengths, ranging from 12 to 30 cm. Renal and vesical loops may be either closed or open. The straight section may be totally or partially reinforced. The eyes are lateral and staggered and are situated every 2 cm along the entire length of the stent (except for the no eye on the straight section version). The ureteral stents have either a fixed core guide-wire, a movable core guide-wire or no guide-wire, depending upon the method of use. The steerable ureferal stents have connectable pushers, and the non-steerable stents have simple pushers. The ureteral stent kits are supplied sterile and for single use only.
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K Number
K021856Device Name
PORGES URETERAL CATHETERS, MODELS ACN6XX, ACN5XX, AC5B, AC5C07, ACP5XX, ACP2XX, ACP3XX, ACP4XX, ACP6XX
Manufacturer
PORGES S.A.
Date Cleared
2002-10-17
(133 days)
Product Code
EYB
Regulation Number
876.5130Why did this record match?
Applicant Name (Manufacturer) :
PORGES S.A.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The PORGES™ Ureteral catheters are used for ureteral catheterisation:
- drainage catheters: straight catheters with bevel, olive or cylindrical tip, elbowed catheter with olive tip
- catheters for retrograde ureteropyelography (R.U.P.): Chevassu, cone or Braasch -
- interventional catheters: flush, open straight, open elbowed. The appropriate quide-wire size for each catheter is shown on the box.
Device Description
The PORGES™ Ureteral catheters consist of a single lumen catheter in medical grade radiopaque polymer, graduated every cm along 50 cm, and fitted with either a metal or a polymer removable stylet or no stylet. The stylet allows straightening of the catheter for easier insertion. A wax knob is added on the external end of the stylet for easy retreat of the coudé tip catheters are fitted with a silicone stop ring on the stylet between the catheter and the wax knob to hold the renal tip of the stylet away from the catheter's renal tip.
The ureteral catheters are available with different types of renal tips and in sizes ranging from 03 FR to 12 FR.
The preamendment devices have been designed for R.U.P. (retrograde ureteropyelography).
PORGES has validated the following uses for the new range of ureteral catheters :
- . drainage
- R.U.P. (= retrograde uretero pyelography) .
- interventional ("per operating") use with a Seldinger guide wire (not supplied)
The PORGES™ Ureteral catheters are supplied sterile and for single use only.
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K Number
K013174Device Name
PROGES FOLYSIL SILICONE FOLEY CATHETER, STRAIGHT CYLINDRICAL TIP, SILICONE FEMALE FOLEY CATHETER, STRAIGHT CYLINDRICAL,
Manufacturer
PORGES S.A.
Date Cleared
2002-01-04
(102 days)
Product Code
EZL
Regulation Number
876.5130Why did this record match?
Applicant Name (Manufacturer) :
PORGES S.A.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The 2-way PORGES™ FOLYSIL™ silicone Foley catheter is used for urethral urinary catheterisation for short term drainage of vesical urines. Only straight 2-way PORGES™ FOLYSIL™ silicone Foley catheter with a maximum 15 ml balloon volume may be used in a supra-pubic way (except the grooved catheters). The 3-way PORGES™ FOLYSIL™ silicone Foley catheter is used for urethral urinary catheterisation to allow short term drainage of the vesical urines, irrigation/injection following surgery.
Device Description
The PORGES™ FOLYSIL™ silicone Foley catheter is of the retention type, commonly called a Foley catheter. The device is a single use, disposable, sterile with retention balloon, which is attached to the silicone shaft. One lumen is for draining fluids to and from the urinary tract. The second lumen is to inflate and deflate the balloon with sterile water. On models with a third lumen, it is used in conjunction with the first lumen for flushing the urinary tract. Sterile water is used for inflation of the balloon. The distal end has opposite eye holes, which are used for drainage. On the Tiemann tip there is one hole. Straight cylindrical, "over the guide wire" and Tiemann tips are available versions of this product. On the opposing end of the shaft, are a connecting funnel and a Luer activated valve. This product is available in sizes 12 Fr to 24 Fr, smooth and profile (grooved) shafts. Profile shafts provide drainage channels along the shaft length.
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K Number
K013172Device Name
PORGES SILICONE PROSTATECTOMY CATHETER, STRAIGHT CYLINDRICAL TIP, DELINOTTE TIP, DUFOUR TIP, OVER THE GUIDE TIP, MODEL
Manufacturer
PORGES S.A.
Date Cleared
2001-12-20
(87 days)
Product Code
EZL
Regulation Number
876.5130Why did this record match?
Applicant Name (Manufacturer) :
PORGES S.A.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The PORGES™ Silicone prostatectomy catheter is used for :
- short term drainage of the vesical urines, -
- irrigation/injection and drainage following surgery,
- infigurer.hijformate surgery : hemostasis of the prostate area.
Device Description
The PORGES™ Silicone prostatectorny catheter is a balloon catheter of the retention type, commonly called THE FORGES " Silkone prosidioning outhere is a banetransparent silicone elastomer with a radiopaque a Toley datable is a single use, disposable, sterile with retention balloon, which is attached to the silicone shaft. One lumen is for draining fluids to and from the urinary tract. The second lumen is to inflate and deflate Shall. One laimer is for araning halas to anyth a third lumen, it is used in conjunction with the first lumen for the ballow with other water in used for inflation and deflation of the balloon. The distal end has opposite eye holes, which are used for drainage.
Nominal balloon inflation volumes are 15 to 30 cm³ or 30 to 50 cm³ with the 15 to 30 cm³ balloon being used Nominal banoon innation for normal usage, and 30 to 50 cm³ when a larger balloon is indicated.
to head of outher in place rehaft, are an connecting funnel and a Luer activated valve of which the colour varies according to the size of the catheter.
This product is available in sizes 18 Fr to 24 Fr, with DUFOUR, DELINOTTE, COUVELAIRE or standard tip. Total length of all catheters : 42 cm. One catheter has an open tip to fit over a guide wire.
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