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510(k) Data Aggregation
K Number
K213855Device Name
Arrow Pressure Injectable Midline Catheter
Manufacturer
Arrow International LLC Subsidiary of Teleflex Incorporated
Date Cleared
2022-09-02
(266 days)
Product Code
PND
Regulation Number
880.5200Why did this record match?
Product Code :
PND
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Arrow(R) Pressure Injectable Midline Catheter is indicated for short-term (≤ 30 days) peripheral access to the venous system for intravenous therapy, blood sampling, infusion, and pressure injection of contrast media. The maximum pressure of pressure injector equipment used with the Arrow Pressure Injectable Midline Catheter may not exceed 300 psi (2068.4 kPa). The maximum pressure injection flow rate for the specific lumen being used for pressure injection is printed on the extension line hub.
Device Description
The Arrow Pressure Injectable Midline Catheter is a non-coated, single use catheter designed to provide short-term peripheral access to the venous system. The midline catheter is a peripherally inserted intravenous catheter manufactured with medical grade, flexible polyurethane. It consists of a non-tapered, radiopaque polyurethane extruded catheter body with a single opening or double opening at the distal end and centimeter markings placed along its length to facilitate its positioning. The catheter is available in 4 Fr. Single lumen and 5 Fr. Double lumen configurations with a usable catheter length of 20 cm. Pinch clamps are an integral part of the catheter and are provided on the extension lines to occlude flow through the lumens, as needed. The catheters can be used for the injection of contrast media. The maximum recommended infusion rate is 5 mL/sec.
The catheters will be packaged sterile in kits that will include components to facilitate insertion.
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K Number
K213203Device Name
Provena(TM) Midline Catheter
Manufacturer
C. R. Bard, Inc.
Date Cleared
2022-05-13
(226 days)
Product Code
PND
Regulation Number
880.5200Why did this record match?
Product Code :
PND
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Provena™ Midline Catheters are indicated for short term access to the peripheral venous system for selected intravenous therapies, blood sampling, and power injection of contrast media. These catheters may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness of the procedure. The Provena™ Midline Catheters are suitable for use with power injectors.
Device Description
Provena™ Midline Catheters are a family of peripherally placed catheters made from radiopaque body-softening polyurethane materials. Each Provena™ Midline Catheter is designed with kink-resistant, reverse taper design. Catheters are packaged in a tray with accessories for reliable short term (less than 30 days) vascular access. The Provena™ Midline Catheters are suitable for use with power-injectors.
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K Number
K210047Device Name
Stiletto Extended Dwell Catheter
Manufacturer
Piper Access, LLC
Date Cleared
2021-08-27
(231 days)
Product Code
PND
Regulation Number
880.5200Why did this record match?
Product Code :
PND
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Stiletto Extended Dwell Catheter is inserted into a patient's vascular system for short-term use (<28 days) to sample blood or administer fluids intravenously. These catheters may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness of the procedure. The Stiletto Extended Dwell Catheter is suitable for use with power injectors.
Device Description
The Stiletto Extended Dwell Catheter (EDC) is a sterile, single use device designed to allow users to sample blood and/or administer fluids over a short duration (<28 days) through a peripherally inserted catheter. The Stiletto EDC utilizes an introducer needle and sheathing cannula to support advancement of a single lumen, power-injectable, catheter into peripheral vasculature. Unique catheter tip geometry is employed that works in conjunction with a sheathing cannula to provide support as the catheter advances into the vessel, providing a reliable method of insertion without need of a guidewire. The catheter, hub and insertion components are integrated into a single housing to enhance ease of use.
The Stiletto EDC will be available in 8 cm and 10 cm lengths with a 20 gauge catheter, and 10 cm and 12 cm lengths with an 18 gauge catheter.
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K Number
K192802Device Name
primeMidline Catheters
Manufacturer
PFM Medical, Inc.
Date Cleared
2019-10-28
(28 days)
Product Code
PND
Regulation Number
880.5200Why did this record match?
Product Code :
PND
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The primeMIDLINE™ Catheters are indicated for short term access to the peripheral venous system for selected intravenous therapies, blood sampling and power injection of contrast media. These catheters are indicated for patients older than 28 days and that weigh more than 10 kg, with consideration given to adequacy of vascular anatomy and appropriateness of the procedure. The primeMIDLINE™ Catheters are suitable for use with power injectors.
Device Description
The 4F DL primeMIDLINE™ Catheter is a peripherally placed midline catheter designed to provide access to the vascular system. The catheter lumen is an open-ended design comprised of radiopaque polyurethane. The 4F DL primeMIDLINE ™ Catheter is packaged sterile in a tray with the accessories necessary to establish short-term (less than 30 days) vascular access. The 4F DL primeMIDLINE Catheter is suitable for use with power injectors.
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K Number
K181208Device Name
Vygon Midline 3 Fr SL Catheter; Vygon Midline 4 Fr SL Catheter; Vygon Midline 5 Fr DL Catheter
Manufacturer
Vygon USA
Date Cleared
2018-11-02
(179 days)
Product Code
PND, VYG
Regulation Number
880.5200Why did this record match?
Product Code :
PND
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The catheters are indicated for short term access to the peripheral venous system intravenous therapies, blood sampling, and power injection of contrast media. These catheters may be used for any patient with consideration given to adequacy of vascular anatomy and appropriateness of the catheters are suitable for use with power injectors.
Device Description
The Vygon Midline Catheters are EO sterilized, single-use, polyurethane, reverse taper, short-term, peripheral venous system access catheters. They include materials containing barium sulfate for radiopacity.
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K Number
K173114Device Name
primeMidline Catheters
Manufacturer
PFM Medical, Inc.
Date Cleared
2018-03-07
(159 days)
Product Code
PND
Regulation Number
880.5200Why did this record match?
Product Code :
PND
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The primeMIDLINE™ Catheters are indicated for short term access to the peripheral venous system for selected intravenous therapies, blood sampling and power injection of contrast media. These catheters are indicated for patients older than 28 days and that weigh more than 10kg, with consideration given to adequacy of vascular anatomy and appropriateness of the procedure. The primeMIDLINE™ Catheters are suitable for use with power injectors.
Device Description
The primeMIDLINE™ Catheters are a family of peripherally placed midline catheters designed to provide access to the vascular system. These catheters are offered in 3F, 4F and 5F Single Lumen and 5F Dual Lumen configurations with 20cm lengths. The catheter lumen is an open-ended design comprised of radiopaque polyurethane. Each primeMIDLINE™ Catheter is packaged sterile in a tray with the accessories necessary to establish short-term (less than 30 days) vascular access. The primeMIDLINE™ Catheters are suitable for use with power injectors.
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K Number
K171483Device Name
ArchFlo CT Midline
Manufacturer
Medcomp (dba Medical Components, Inc.)
Date Cleared
2017-12-15
(207 days)
Product Code
PND
Regulation Number
880.5200Why did this record match?
Product Code :
PND
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Arch-Flo CT Midline is indicated for Short-Term peripheral venous system for selected intravenous therapies, blood sampling, and power injection of contrast media. This catheter may be inserted via basilic, cephalic, or median cubital vein.
Device Description
The Arch-Flo'™ CT Midline is available in a 4F Single Lumen configuration. The catheter lumen terminates through an extension to a female luer-lock connector. The extension has an in-line clamp to control fluid flow and is marked POWER INJECTABLE MIDLINE along with the lumen gauge size. The transition between lumen and extension is housed within a molded hub. The hub is marked MIDLINE to identify that the catheter is not centrally placed. The tip of the lumen is notched to increase the exposed area of the lumen. The outside diameter of the lumen increases gradually near the hub to aid in kink resistance and to provide a mechanical obstruction to bleeding from the venotomy. The lumen is marked with depth marks every centimeter.
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K Number
K170770Device Name
CT Midline
Manufacturer
Medical Components, Inc. (dba Medcomp)
Date Cleared
2017-07-25
(133 days)
Product Code
PND
Regulation Number
880.5200Why did this record match?
Product Code :
PND
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CT Midlines are indicated for Short-Term peripheral access to the peripheral venous system for selected intravenous therapies, blood sampling, and power injection of contrast media. The maximum recommended infusion rate varies by catheter French size and is printed on the catheter.
Device Description
The CT Midline Catheter is designed for peripheral vein catheterization and power injection of contrast media. The lumen is an open-ended design comprised of a soft radiopaque polyurethane material with barium sulfate for radiopacity. The lumen is connected to the extensions via a soft pliable hub with suture wing for secure placement. Clamps are provided on the extension tubes to prevent air/fluid contamination. Female luer connectors provide the connection for intravenous administration.
The CT Midline Catheter is available in a 4Fx20cm single-lumen, or 5Fx20cm double-lumen configuration. The outside diameter of the lumen has a reverse taper increasing gradually near the hub to aid in kink resistance and to provide a mechanical obstruction to bleeding from the venotomy. The lumen has depth marks every centimeter and numerical marks every fifth centimeter. The CT Midline is packaged sterile with the necessary accessories to facilitate insertion.
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K Number
K170158Device Name
PowerGlide ST Midline Catheter
Manufacturer
C. R. Bard, Inc.
Date Cleared
2017-06-01
(134 days)
Product Code
PND
Regulation Number
880.5200Why did this record match?
Product Code :
PND
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The PowerGlide ST™ Midline Catheter is inserted into a patient's vascular system for short term use to sample blood or administer fluids intravenously. These catheters may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness of the procedure. The PowerGlide ST™ Midline Catheter is suitable for use with power injectors.
Device Description
Bard Access Systems, Inc.'s PowerGlide ST™ Midline Catheter is a sterile, single use device designed to provide access to the patient's vascular system. The device is intended for short term use (<30 days) to sample blood and administer fluids intravenously. The subject device consists of a single lumen, radiopaque, body softening polyurethane catheter rated for power injection, and a dilator (when applicable). Additional procedural kit accessories (e.g. introducer needle and guidewire) are included to facilitate catheter placement. The PowerGlide ST™ Midline Catheter is offered in 18, 20, and 22 gauge sizes. The 18 and 20 gauge devices are offered in 8 cm or 10 cm lengths with an integrated dilator. The 22 gauge device is offered in only an 8 cm length and does not include a dilator.
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K Number
K162900Device Name
PowerMidline Catheter
Manufacturer
C.R. Bard, Inc.
Date Cleared
2016-12-14
(58 days)
Product Code
PND, LJS
Regulation Number
880.5200Why did this record match?
Product Code :
PND
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The PowerMidline™ Catheters are indicated for short term access to the peripheral venous system for selected intravenous therapies, blood sampling, and power injection of contrast may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness of the procedure. The PowerMidline™ Catheters are suitable for use with power injectors.
Device Description
The dual lumen PowerMidline™ catheters are a family of peripherally placed catheters made from radiopaque body-softening polyurethane materials. Each dual lumen PowerMidline™ catheter is designed with kink-resistant, reverse taper design. The dual lumen PowerMidline™ catheters are offered in a 4 F dual lumen (DL) and 5 F dual lumen (DL) configuration for reliable short term (less than 30 days) vascular access. These catheters are offered in 20 cm trimmable lengths. The dual lumen PowerMidline™ catheters are suitable for use with power injectors.
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