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510(k) Data Aggregation
K Number
K250972Device Name
Primum Hydrophilic Guiding Catheter
Manufacturer
PendraCare
Date Cleared
2025-06-29
(90 days)
Product Code
DQY
Regulation Number
870.1250Why did this record match?
Product Code :
DQY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Guiding Catheter is designed to provide a pathway through which therapeutic and diagnostic devices are introduced. The Guiding Catheter is intended to be used in the coronary or peripheral vascular system.
Device Description
The Hydrophilic Guiding Catheter consists of a reinforced body with a hub and strain relief at the proximal end and an intermediate and soft tip at the distal end. The distal part of the catheter features a specific tip shape. A part of the catheter body features a hydrophilic coating. The (distal part of the) catheter body is provided either with or without "in-line" side holes.
The guiding catheter is a flexible plastic tube featuring a luer hub, strain relief, a body, an intermediate tip, and a soft tip. The body and the intermediate tip consist of an inner liner (basecoat) and an outer jacket (topcoat) reinforced with a tightly wound stainless steel braid wire in between the layers. The central lumen of the catheter is used for the percutaneous, transluminal passage and placement of guidewires, diagnostic and therapeutic devices within the vascular system. After the catheter is inserted through the skin using a dilator, a sheath (introducer) and guide wire is brought into position. Subsequently, a guidewire is advanced through its lumen and tracked over by a diagnostic device and/or a therapeutic devices to the intended location. The distal section of the catheters has a variety of preformed shapes (e.g. Judkins Left (abbreviated as JL), Judkins Right (JR), Amplatz (AL), Multi-purpose (MP), hockey stick) to facilitate placement of the catheter tip in the desired target vessel. Some catheter models feature two (2) small "in-line" side holes in the intermediate tip section to maintain perfusion of the target vessel. This device is a single-use device (i.e., single patient, single procedure, single purpose use). After finalizing the procedure, the catheter is withdrawn, removed and discarded.
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K Number
K250828Device Name
CPS Locator 3D Plus Delivery Catheter
Manufacturer
CenterPoint Systems LLC
Date Cleared
2025-06-27
(100 days)
Product Code
DQY
Regulation Number
870.1250Why did this record match?
Product Code :
DQY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Delivery Catheter is indicated for the introduction of various types of catheters and pacing or defibrillator leads.
Device Description
The modified Delivery Catheter (CPS Locator 3D Delivery Catheter) is a single-use percutaneous catheter indicated for the introduction of various types of catheters and pacing or defibrillation leads.
The modified Delivery Catheter is packaged with a dilator for introduction into the vasculature. Proximally, the modified Delivery Catheter is equipped with a hemostatic valve, and the distal soft, rounded, radiopaque tip facilitates imaging under fluoroscopy. The modified Delivery Catheter is designed to be slittable, thereby allowing its removal after device placement. A variety of curves and lengths are available to accommodate various anatomies and different locations.
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K Number
K243184Device Name
SAT CenterFlow Molding Balloon Catheter (IN20-00313)
Manufacturer
Strait Access Technologies Holdings
Date Cleared
2025-06-25
(268 days)
Product Code
DQY
Regulation Number
870.1250Why did this record match?
Product Code :
DQY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CenterFlow Molding Balloon Catheter is intended to assist in the dilatation of self-expanding endoprostheses in large diameter vessels.
Device Description
The CenterFlow Molding Balloon Catheter is intended to assist in the dilatation of self-expanding endoprostheses in large diameter vessels. When used in its indications for use, it is a low-permissive, over-the-wire, single-use device comprised of two elongated non-compliant nylon balloons that are attached to and within a nitinol support frame. The two elongated balloons are constrained in a zigzag arrangement by the nitinol support frame. Upon inflation, this configuration enables expansion of the device head through balloon straightening, to assist the dilatation of self-expanding endoprostheses in large diameter vessels. Expansion of the zig-zag balloon configuration creates a central orifice permitting maintained hemodynamic flow during the molding procedure. The inflation lumen is 9 Fr and is made of PEBAX 72D. A co-axial PEBAX 72D guidewire lumen runs through the inflation lumen and device head and terminates into a distal polycarbonate tip. Two platinum-iridium markers provide angiographic visualization of the distal and proximal balloon edges to facilitate intravascular balloon placement prior to inflation. The catheter has a working length of 110 cm and it connects proximally to a standard Y-connector at the proximal end. The Y-connector allows for separation of two lumens - an angled luer-lock hub to inflate and deflate the balloon and a straight luer-lock hub which accepts a 0.035" guidewire. The device is deflated and inserted over the guidewire through the hemostasis valve of a transfemoral introducer sheath.
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K Number
K250492Device Name
FlexiGo 3D Delivery Catheter
Manufacturer
CenterPoint Systems LLC
Date Cleared
2025-06-18
(118 days)
Product Code
DQY
Regulation Number
870.1250Why did this record match?
Product Code :
DQY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Delivery Catheter is intended for the venous introduction of pacing or defibrillation leads.
Device Description
The modified Delivery Catheter (FlexiGo 3D Delivery Catheter) is a single-use percutaneous catheter intended for venous introduction of pacing or defibrillation leads.
The modified Delivery Catheter is packaged with a dilator and two (2) trans vavular introducers for introduction into the vasculature. Proximally, the modified Delivery Catheter is equipped with a hemostatic valve, and the distal soft, rounded, radiopaque tip facilitates imaging under fluoroscopy. The modified Delivery Catheter is designed to be slittable, thereby allowing its removal after device placement. A variety of curves and lengths are available to accommodate various anatomies and different locations.
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K Number
K250219Device Name
Dorado PTA Balloon Dilatation Catheter
Manufacturer
Bard Peripheral Vascular, Inc.
Date Cleared
2025-06-17
(144 days)
Product Code
DQY
Regulation Number
870.1250Why did this record match?
Product Code :
DQY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Dorado™ PTA Balloon Dilatation Catheter is recommended for Percutaneous Transluminal Angioplasty (PTA) of the renal, iliac, femoral, popliteal, tibial, peroneal, and subclavian arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also recommended for post-dilatation of balloon expandable and self expanding stents in the peripheral vasculature. This catheter is not for use in coronary arteries.
Device Description
The Dorado™ PTA Balloon Dilatation Catheter is a high-performance balloon catheter consisting of an over the wire catheter with a balloon fixed at the distal tip. The proprietary non-compliant, low-profile balloon is designed to provide consistent balloon diameters and lengths even at high pressures. Two radiopaque markers delineate the working length of the balloon and aid in balloon placement. The catheter includes an atraumatic tip to facilitate advancement of the catheter to and through the stenosis. The novel catheter consists of a distal triple lumen and a proximal coaxial lumen and is designed to optimize the balance between pushabilty and trackability. The over the wire catheter is compatible with 0.035" guidewire and is available in 40, 80, 120, and 135 cm working lengths. The proximal portion of the catheter includes a female luer lock hub connected to the inflation lumen, and a female luer-lock hub connected to the guidewire lumen. Packaged with every product is a profile reducing sheath that is positioned over the balloon for protection before use. A re-wrapping tool is also provided on the catheter shaft. A stylet is placed into the tip of the catheter to aid in rewrap/refolding of the balloon. These products are not made with natural rubber latex.
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K Number
K250410Device Name
GORE® Tri-Lobe Balloon Catheter
Manufacturer
W. L. Gore & Associates, Inc.
Date Cleared
2025-06-02
(109 days)
Product Code
DQY
Regulation Number
870.1250Why did this record match?
Product Code :
DQY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The GORE® Tri-Lobe Balloon Catheter is intended to assist in the dilatation of self-expanding endoprostheses in large diameter vessels.
Device Description
The GORE® Tri-Lobe Balloon Catheter is a compliant, tri-lobed polyurethane balloon catheter. The lobed design of the balloon catheter is designed for inflation without complete blockage of aortic blood flow. The three polyurethane balloons are mounted on the leading end of a multi-lumen catheter shaft. Radiopaque markers indicate the balloon edges. Each of the three inflation lumens is in communication with one of the balloons. The inflation port is in communication with all of the inflation lumens and is affixed with a luer lock. The guidewire lumen allows introduction of a 0.035" (0.89 mm) diameter guidewire for over-the-wire access. The trailing end of the guidewire lumen is affixed with a flushing/guidewire port with a luer lock, used for flushing the guidewire lumen. A Tuohy-Borst valve is integrated into the trailing end of the guidewire lumen.
The GORE® Tri-Lobe Balloon Catheter is available in two sizes. The smaller balloon can be inflated to diameters of 16 mm to 32 mm and the larger balloon can be inflated to diameters of 26 mm to 48 mm.
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K Number
K243757Device Name
Shockwave CS Guide Catheter
Manufacturer
Shockwave Medical, Inc.
Date Cleared
2025-05-02
(147 days)
Product Code
DQY
Regulation Number
870.1250Why did this record match?
Product Code :
DQY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Shockwave CS Guide Catheter is intended to access the coronary venous system and may be used alone (9F) or in a dual catheter delivery (e.g., 9F with 7F). The catheter serves as a conduit for the introduction of interventional/diagnostic devices introduced into the coronary venous system.
Device Description
The Shockwave CS Guide Catheter is a single lumen catheter consisting of a PTFE liner, stainless steel braid, and polymer outer jacket. The transition segments of the catheter have a gradual decrease in stiffness starting from the proximal shaft segment and ending at the distal tip. The Shockwave CS Guide Catheter features a curved distal shaft with radiopaque tip. The proximal end of the guide catheter has a standard luer fitting for connecting to a hemostasis valve. The proximal luer also includes a curve indicator to match the direction of the guide catheter tip curvature and provides a tactile and visual cue to the user. The Shockwave CS Guide Catheter is provided EO sterile and is for single use only.
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K Number
K251014Device Name
APRO 45 Catheter
Manufacturer
Alembic, LLC
Date Cleared
2025-05-01
(29 days)
Product Code
DQY, QJP
Regulation Number
870.1250Why did this record match?
Product Code :
DQY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The APRO 45 Catheter is indicated for use in facilitating the insertion and guidance of appropriately sized interventional devices into a selected blood vessel in the peripheral and neurovascular systems. The APRO 45 Catheter is also indicated for use as a conduit for retrieval devices.
Device Description
The APRO 45 Catheter is a single-lumen, braid and coil reinforced catheter. The APRO 45 Catheter is designed to facilitate the insertion and guidance of interventional devices into peripheral and neuro vasculature. Using standard catheterization techniques under fluoroscopic guidance, the APRO 45 Catheter is introduced through a guide catheter or guide sheath and over a guidewire into the target vasculature. The distal segment of the catheter shaft has a hydrophilic coating to aid navigation through the vasculature. A radiopaque marker is located at the distal tip of the catheter for visualization under fluoroscopy. The APRO 45 Catheter is provided with an Introducer Sheath. The APRO 45 Catheter contains animal derived materials made from tallow derivatives.
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K Number
K250962Device Name
APRO 55 Intermediate Catheter
Manufacturer
Alembic, LLC
Date Cleared
2025-04-29
(29 days)
Product Code
DQY
Regulation Number
870.1250Why did this record match?
Product Code :
DQY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The APRO 55 Intermediate Catheter is indicated for use in facilitating the insertion and guidance of appropriately sized interventional devices into a selected blood vessel in the peripheral and neurovascular systems. The APRO 55 Intermediate Catheter is also indicated for use as a conduit for retrieval devices.
Device Description
The APRO 55 Intermediate Catheter is a single-lumen, braid and coil reinforced catheter. The catheter is designed to facilitate the insertion and guidance of interventional devices into peripheral and neuro vasculature. Using standard catheterization techniques under fluoroscopic guidance, the APRO 55 Intermediate Catheter is introduced through a guide catheter or guide sheath and over a guidewire into the target vasculature. The distal segment of the catheter shaft has a hydrophilic coating to aid navigation through the vasculature. A radiopaque marker is located at the distal tip of the catheter for visualization under fluoroscopy. The catheter is provided with an Introducer Sheath.
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K Number
K250426Device Name
Amulet Steerable Delivery Sheath
Manufacturer
Abbott Medical
Date Cleared
2025-04-25
(70 days)
Product Code
DQY
Regulation Number
870.1250Why did this record match?
Product Code :
DQY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Amulet™ Steerable Delivery Sheath is indicated to facilitate the delivery of the Amplatzer™ Amulet™ Left Atrial Appendage Occluder.
Device Description
The Amulet™ Steerable Delivery Sheath is designed to provide a pathway through which a device may be delivered. The sheath is provided in one size (14F), with a working length of 75 cm and a bi-directional distal tip to provide positioning in the cardiac anatomy. The handle is equipped with a deflection knob to deflect the tip clockwise 120° and counterclockwise 0°. The body of the sheath is radiopaque for visibility under fluoroscopy and has a marker band located in the distal tip. The dilator eases penetration of tissue. The sheath and dilator utilize a dual curve in two dimensions, resulting in a three-dimensional geometry. The 14F flush adapter facilitates the attachment of additional components.
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