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510(k) Data Aggregation
K Number
K152876Device Name
LONG SHEATH OR LS, 70 CM, LONG SHEATH OR LS, 80 CM, LONG SHEATH OR LS, 90 CM
Manufacturer
TNI Manufacturing, Inc.
Date Cleared
2016-01-08
(100 days)
Product Code
DQY
Regulation Number
870.1250Why did this record match?
Applicant Name (Manufacturer) :
TNI Manufacturing, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Long Sheath is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasulature.
Device Description
The Long Sheath or LS is a variable stiffness catheter and has a catheter shaft reinforced with a stainless steel braid and has a radiopaque Platinum/Iridium marker band on the distal end. The catheter has a nominal outer diameter of 0.109 inches. It is available with a nominal inner diameter of 0.088 inches. They are available in three working lengths: 70 cm, 80 cm, and 90 cm. The Long Sheath has a PTFE-lined lumen, which is braidreinforced, flexible, and has a hydrophilic coating. The LS are inserted through a guide catheter or vascular sheath, provide access to the target site and once in place, provide a reinforcing conduit for other intravascular devices. Accessories included with the device are a Tuohy-Borst hemostasis valve with an extension luer and a dilator. The LS is supplied sterile, non-pyrogenic, and intended for single use only.
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K Number
K152202Device Name
Intermediate Catheter, 105 cm, Intermediate Catheter, 115cm, Intermediate Catheter , 125cm
Manufacturer
TNI Manufacturing, Inc.
Date Cleared
2015-12-14
(130 days)
Product Code
DQY, DTL, DYB
Regulation Number
870.1250Why did this record match?
Applicant Name (Manufacturer) :
TNI Manufacturing, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Intermediate Catheter is indicated for the introduction of interventional devices into the peripheral and neuro vasculature.
Device Description
The Intermediate Catheter is a variable stiffness catheter and has a catheter shaft reinforced with a stainless steel braid, a stainless steel coil, a Nitinol coil, and has a radiopaque Platinum/Iridium marker band on the distal end. The catheter has a nominal distal outer diameter of 0.072" and a nominal proximal outer diameter of 0.078". It is available with a nominal inner diameter of 0.060". They are available in three working lengths, 105 cm, 115 cm. and 125 cm. The Intermediate Catheters have a PTFE-lined lumen, which is braid and coil reinforced, flexible, and has a hydrophilic coating. The Intermediate Catheters are inserted through a guide catheter or vascular sheath, provide access to the target site and once in place, provides a reinforcing conduit for other intravascular devices. Accessories included with the device are a Tuohy-Borst hemostasis valve and a split introducer sheath. The Intermediate Catheter is supplied sterile, non-pyrogenic, and intended for single use only.
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