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510(k) Data Aggregation
K Number
K982797Device Name
BLUNT T-PEEL INTRODUCER MODEL NUMBER PE-16PICB, PE-18PICB, PE-20PICB, PE-24PICB
Manufacturer
Date Cleared
1998-11-30
(112 days)
Product Code
Regulation Number
870.1340Why did this record match?
Applicant Name (Manufacturer) :
LUTHER MEDICAL PRODUCTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Blunt T-Peel Plastic Sheath Introducer is used to facilitate placement of a peripherally inserted intravenous catheter through the skin into a vein and when used according to the Directions For Use, may reduce the risk of an accidental needlestick.
Device Description
An over-the-needle peel-away plastic sheath catheter introducer which includes a blunting feature to blunt the tip of the needle after venous access.
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K Number
K980090Device Name
ONECATH, L-CATH CATHETER SYSTEM, MODEL OC-(16-22 GA., 5CM-60CM)
Manufacturer
Date Cleared
1998-03-24
(74 days)
Product Code
Regulation Number
880.5970Why did this record match?
Applicant Name (Manufacturer) :
LUTHER MEDICAL PRODUCTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The ONECATH Catheter System is designed for use when patient therapy requires repeated venous access or prolonged intravenous administration of fluids, medications, and/or nutritional solutions as prescribed. The catheter is designed to be inserted in a peripheral vein. While any vessel suitable for insertion may be used; the basilic vein is the most commonly used vein.
Device Description
The ONECATH Catheter System consists of a SafeSide DEVICE DESCRIPTION: II® introducer and a radiopaque single lumen polyurethane catheter with a clear tip. The SafeSideII introducer consists of a stainless steel needle and a two-part locking needle protection device with a flashback chamber and introducer protector. The 60, 50 and 20 cm catheters are marked in 5cm increments, in a linear tear protective sleeve. For the 60, 50 and 20 cm catheters a stylet is pre-inserted through the Y-site injection port that is connected to the catheter. A vent plug is inserted in the side port of the Y-site. The SafeSide II introducer is pre-inserted in the catheter through an aperture approximately 2cm from the tip. The ONECATH catheter system is available in various lengths of 60. 50 and 20 cm and is packaged in a two-part tray in a pouch. The ONECATH 5cm catheter is packaged in a pouch with a hemostasis valve. The product contains no DEHP or latex. The female luer is lipid resistant. Non serrated forceps are included.
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K Number
K974543Device Name
L-CATH MODIFIED SELDINGER TECHNIQUE INSERTION/CATHETER EXCHANGE KIT PE-MST24-24 GA. KIT, L-CATH MODIFIED SELDINGER
Manufacturer
Date Cleared
1998-02-10
(69 days)
Product Code
Regulation Number
880.5200Why did this record match?
Applicant Name (Manufacturer) :
LUTHER MEDICAL PRODUCTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The L-Cath Modified Seldinger Technique Accessory Kit is designed for placement and/or exchange of the L-Cath Peripherally Inserted Catheter System in 16 ga. (5Fr.), 18 ga. (4Fr.), 20 ga. (3Fr.), 24 ga. (2.6 Fr.) and the L-Cath Dual Lumen 16 and 18 ga.
Utilization of a Modified Seldinger Technique for catheter placement has been demonstrated to be effective for the placement of peripherally inserted central catheters in patients, pediatric and adult, with difficult to access veins.
Device Description
The L-Cath Modified Seldinger Technique Kit consists of over-the-needle insertion catheters, a scalpel, measuring tape, sterile drapes, scissors, needle holder, syringe, with a sheath dilator and guide wire, in appropriate sizes to accommodate the Luther Medical line of Peripherally Inserted Catheters, the "parent devices". Included in the kit are appropriate accessories to aid in this technique.
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