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Found 17 results
510(k) Data Aggregation
K Number
K213602Device Name
Argyle Peritoneal Dialysis Cathetor and Kit, Ritus Peritoneal Dialysis Catheter Tunneling Tool Kit
Manufacturer
Covidien, llc
Date Cleared
2022-01-14
(60 days)
Product Code
FJS
Regulation Number
876.5630Why did this record match?
Product Code :
FJS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Ritus™ tunneling tool kit is used to both create a tunnel tract through subcutaneous tissue and seal the end of the catheter. This allows the external portion of the Covidien™ peritoneal dialysis catheter to be temporarily buried in advance of dialysis for patients that are candidates for delayed peritoneal dialysis treatment.
Device Description
The Ritus™ tunneling tool kit comes with a separate tunneling device and plug. This kit is designed to create a subcutaneous tunnel to temporarily bury the external portion of the peritoneal dialysis catheter within the abdominal, subcutaneous tissue in advance of needing dialysis.
The tunneling device is made of stainless steel with a rigid plastic handle on the proximal end. There is an angled tip with a removable plastic cap. Functioning as a dilator, the tunneling device separates the tissue to create a tunnel tract, then is used to pull the catheter through the tunnel to desired exit site.
The titanium catheter plug is designed to seal the end of the catheter for the length of time that the catheter is buried within the subcutaneous tissue.
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K Number
K180485Device Name
Argyle Peritoneal Dialysis Catheter and Kits, Argyle Presternal Peritoneal Dialysis Catheter and Kits, Argyle Peritoneal Dialysis Accessory Two Part Titanium Luer Adapter, Argyle Adult Peritoneal Dialysis Accessory Titanium Catheter Extender
Manufacturer
Covidien, llc
Date Cleared
2018-07-27
(154 days)
Product Code
FJS, FKO
Regulation Number
876.5630Why did this record match?
Product Code :
FJS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Argyle(TM) Peritoneal Dialysis Catheter and Kits:
The peritoneal catheter is indicated for acute and chronic peritoneal dialysis.
The peritoneal dialysis catheter may be inserted using open, laparoscopic or percutaneous surgical techniques.
Argyle (TM) Presternal Peritoneal Catheter and Kits:
The presternal peritoneal catheter is indicated for acute and chronic peritoneal dialysis.
The Peritoneal Dialysis catheter may be inserted using open, laparoscopic or percutaneous surgical techniques.
Argyle(TM) Peritoneal Dialysis Accessory Two Part Titanium Luer Adapter:
The Two Part Titanium Luer Adapter is indicated for acute and chronic peritoneal dialysis, to be used with the Argyle(TM) Peritoneal Dialysis Catheter and the Argyle(TM) Presternal Peritoneal Dialysis Catheter. The Two Part Titanium Luer Adapted to provide a permanent threaded closure when used with a standard continuous ambulatory peritoneal dialysis (CAPD) transfer set.
Argyle(TM) Adult Peritoneal Dialysis Accessory Titanium Catheter Extender
The Titanium Catheter Extender is indicated for acute and chronic peritoneal dialysis, to be used with the Argyle(TM) Peritoneal Dialysis Catheter and the Argyle(TM) Presternal Peritoneal Dialysis Catheter.
The adult catheter extender is used to extend a catheter by connecting two portions of the peritoneal catheter tubing.
Device Description
The Argyle™ Peritoneal Dialysis Catheter products are single lumen catheters for acute and chronic peritoneal dialysis to allow consistent bi-directional flow of dialysate into and out of the abdominal cavity. One or more cuffs are bonded on to the catheter tubing, which allows for tissue ingrowth to maintain placement of the catheter. All catheters are made of translucent silicone rubber tubing containing a radiopaque stripe, with felt cuffs available to provide catheter stabilization by virtue of tissue in-growth.
The Argyle™ peritoneal dialysis catheter comes in a variety of lengths and cuff configurations including straight, curled, and Swan Neck catheter styles. The Argyle™ peritoneal dialysis catheter kit contains the basic items needed to insert a peritoneal catheter: a straight or Swan Neck Tenckhoff or Curl Cath catheter with single or double cuff (specified at time of order), a 16 Fr/Ch pull-apart introducer, an 18 G introducer needle, a 12 mL syringe, a J/straight guidewire, tunneling stylet, #11 scalpel, gauze sponges, Beta-Cap™ adapter, cap, clamp, and instructions.
The Argyle™ presternal peritoneal dialysis catheters include the curl catheter and Swan Neck catheter styles. The curl catheter segment contains a felt cuff. The Swan Neck Presternal catheter is a segment of catheter tubing with a Swan Neck bend and two cuffs. It is connected by a double-barbed connector to the intraperitoneal segment of the curl catheter. The Argyle™ presternal peritoneal dialysis catheter kit contains the basic items needed to insert a peritoneal catheter: a 16 Fr/Ch pull-apart introducer, an 18 G introducer needle, a 12 mL syringe, a J/straight guidewire, tunneling stylet, #11 scalpel, gauze sponges, Beta-CapTM adapter, cap, clamp, titanium connector, and instructions.
The titanium adapter is a two-piece luer-lock system with a barbed end and a threaded cover. The adapter is designed to provide a permanent threaded closure when used with a standard CAPD transfer set.
The adult catheter extender is double barbed and made of titanium. The adult catheter extender is used to extend a catheter by connecting two portions of the peritoneal catheter tubing.
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K Number
K130441Device Name
FALLER STYLET
Manufacturer
MEDIONICS INTERNATIONAL, INC.
Date Cleared
2013-04-19
(57 days)
Product Code
FJS
Regulation Number
876.5630Why did this record match?
Product Code :
FJS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Faller stylet is a surgical tool used to create a subcutaneous tunnel for a peritoneal dialysis catheter, from the initial implantation site to the preferred exit-site. It separates the tissue as it leads the catheter through to the skin exit-site.
Device Description
Faller Stylet
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K Number
K121383Device Name
PS X SERIES (BASIC COMPONENTS AND CATHETER), PD X SERIES (CATHETER WITH ALL COMPONENTS)
Manufacturer
MEDICAL COMPONENTS INC
Date Cleared
2012-09-05
(120 days)
Product Code
FJS
Regulation Number
876.5630Why did this record match?
Product Code :
FJS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The "X" Series PD Catheter is indicated for peritoneal dialysis in adults. It is intended for use in patients who are poor candidates for conventional peritoneal dialysis catheters and are candidates for presternal insertion.
The "X" Series Catheter is indicated for chronic peritoneal dialysis.
The extended length of the “X” Series Catheter makes it especially applicable for peritoneal dialysis patients when it is necessary to locate the skin exit site remote from the usual lower abdominal region. The catheter may be particularly indicated in patients with obesity, floppy abdominal skin folds, urinary or fecal incontinence, chronic yeast intertrigo, intestinal stomas, or in patients who desire to take deep tub baths.
Device Description
The "X" Series PD Catheter is comprised of a silicone rubber, coiled tip, single polyester cuff abdominal catheter segment that is joined with a titanium double bared connector to a silicone rubber, double polyester cuff subcutaneous extension catheter possessing a preformed tubing arc bend between the two cuffs. The abdominal catheter segment is implanted into the peritoneal cavity. The attached subcutaneous extension piece allows remote location of the catheter skin exit site away from the lower abdominal region.
The catheter will be sold in two kit configurations, as the catheter only with a female luer, clamp, and male luer end cap and titanium connector. The catheter set will also include the addition of a dilator/sheath introducer, guidewire, scalpel, introducer needle, tunneling tool, gauze pads and syringe.
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K Number
K120130Device Name
FALLER TROCAR
Manufacturer
MEDIGROUP, INC.
Date Cleared
2012-05-21
(125 days)
Product Code
FJS, CLA
Regulation Number
876.5630Why did this record match?
Product Code :
FJS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Faller Trocar is used to create an ante-grade subcutaneous tunnel for a peritoneal dialysis catheter from the initial implantation site to the preferred exit-site. It separates the tissue as it leads the catheter through to the skin exit-site.
Device Description
The Faller Trocar is a surgical tool, made of either stainless steel or approved plastic, with a barbed section on one end and a sharp tip on the other end. The device is curved so that the physician using it can follow a tunnel path to lead the catheter from the initial catheter implantation site to the exit-site in an ante-grade manner.
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K Number
K113354Device Name
VETA PERITONEAL DIALYSIS CATHETER
Manufacturer
PFM MEDICAL, INC
Date Cleared
2012-03-13
(120 days)
Product Code
FJS
Regulation Number
876.5630Why did this record match?
Product Code :
FJS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Veta Peritoneal Dialysis Catheter is indicated for acute and chronic access to the peritoneal cavity. The Veta Peritoneal Dialysis Catheters will be used to drain and infuse fluid during peritoneal dialysis procedures.
Device Description
Veta™ Peritoneal Dialysis Catheters are side-ported silicone catheters with a single and double retention cuff, available in a range of lengths and French sizes and in either a straight or spiral tip configuration.
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K Number
K071167Device Name
FLEX-NECK EXXTENDED PERITONEAL DIALYSIS CATHETER AND ACCESSORIES, MODEL CF-5560
Manufacturer
MEDIGROUP, INC.
Date Cleared
2007-08-31
(127 days)
Product Code
FJS
Regulation Number
876.5630Why did this record match?
Product Code :
FJS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
If a patient is a suitable adult candidate for peritoneal dialysis (PD) therapy, the Flex-Neck® ExxTended ™ peritoneal dialysis catheter can be implanted either surgically, laparoscopically, or peritoneoscopically for acute or chronic peritoneal dialysis. Stencils sold with the device, and marketed separately, will be used to assist the physician to locate the optimum primary implantation site and the optimum catheter exit site for the Flex-Neck® ExxTended™ Catheter.
Device Description
This device consists of a two-part peritoneal dialysis catheter and accessories. The catheter is made of long-term, implantable grade silicone tubing with a radiopaque strip, and two cuffs made of polvester felt. The coiled lower catheter section (with one rectus cuff) connects to an arcuate upper catheter section (with one exit cuff) via a tube-to-tube titanium connector (included), secured with a nonabsorbable nylon suture (not included). Also included in the catheter package is a set of stencils (right and left) to assist the physician to locate the optimum primary implantation site and the optimum catheter exit site below the sternum. (Note: In addition to being packaged with each catheter, this stencil set will be sold sterile, packaged by itself, so the physician or other qualified personnel can use it in a clinical setting prior to the implantation.) Also included in the packaging will be a surgical grade marking pen, a tape measure, a plastic catheter connector and cap, a packet of water-soluble lubricating gel, and an ExxTended™ tunneling tool.
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K Number
K070730Device Name
FLEX-NECK ARC CATHETER
Manufacturer
MEDIGROUP, INC.
Date Cleared
2007-07-03
(110 days)
Product Code
FJS
Regulation Number
876.5630Why did this record match?
Product Code :
FJS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
If a patient is a suitable candidate for peritoneal dialysis (PD) therapy, the Flex-Neck® ARC ™ peritoneal dialysis catheter can be implanted either surgically, laparoscopically, or peritoneoscopically for acute or chronic peritoneal dialysis.
Device Description
This device consists of a peritoneal dialysis catheter and accessories. The catheter is made of long-term, implantable grade silicone tubing with a radiopaque strip, and one or two cuffs made of polyester felt. The coiled catheter has a permanent bend and is available in three adult variations, three pediatric/adolescent variations, and two infant variations. Included in the catheter package is a set of stencils (right and left) to help determine which configuration of catheter to implant and to assist the physician to locate the optimum primary and secondary incision sites. (Note: In addition to being packaged with each catheter, this stencil set will be sold sterile, packaged by itself, so the physician or other qualified personnel can use it in a clinical setting prior to the implantation.) Also packaged with the catheter will be a surgical grade marking pen, a plastic catheter connector and cap, and a packet of water-soluble lubricating gel.
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K Number
K060897Device Name
EMBEDDING TOOL, MODEL TE-1000
Manufacturer
MEDIGROUP, INC.
Date Cleared
2006-07-18
(106 days)
Product Code
FJS
Regulation Number
876.5630Why did this record match?
Product Code :
FJS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This device can be used to embed most known brands and styles of PD catheters when the nephrologist determines this action is in the best interest of the patient, however, only immediately after successful catheter implantation.
The Embedding™ Tool is indicated for embedding the external portion of most PD catheters subcutaneously in anticipation of future retrieval of that part of the catheter, provided that:
- The embedding procedure is done immediately following PD . catheter implantation.
- Catheter patency has been completely established. .
- The normally external part of the PD catheter can be embedded. .
- The patient is a candidate for delayed onset of PD treatment. .
- The patient is a candidate for PD. .
Device Description
The Embedding™ Tool consists of a gently curved handle portion made of rigid PVC with a detachable titanium tip and a separate titanium cap.
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K Number
K053123Device Name
PD CATH
Manufacturer
MED-CONDUIT, INC.
Date Cleared
2006-03-29
(142 days)
Product Code
FJS
Regulation Number
876.5630Why did this record match?
Product Code :
FJS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The PD Cath is indicated for use in attaining long term peritoneal access for peritoneal dialysis via the peritoneum. The catheter is intended for implantation dwell time of greater than 30 days.
Device Description
The PD Cath is a radiopaque silicone, single lumen catheter used to insert and remove peritoneal fluid. The fixed Dacron cuff allows for tissue ingrowth for long-term placement. A flexible silicone overtube is permanently bonded to the lumen passages and the cuff to insulate the cuff from forces applied to the external or internal lumens.
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