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510(k) Data Aggregation
K Number
K191305Device Name
Hereaeus Poseidon Microcatheter
Manufacturer
Heraeus Medical Components, LLC
Date Cleared
2019-12-19
(219 days)
Product Code
KRA, DQY
Regulation Number
870.1210Why did this record match?
Applicant Name (Manufacturer) :
Heraeus Medical Components, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Poseidon Microcatheter is intended for use in peripheral and coronary vessels for diagnostic and interventional procedures including small or superselective anatomy.
Device Description
The Poseidon Microcatheter is a single lumen catheter constructed using an internal lubricious layer encapsulated by a metallic braid and lubricious outer layer. The distal tip includes a radiopaque marker band, and the distal 60 - 90 cm of the microcatheter has a hydrophilic coating.
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K Number
K191502Device Name
Heraeus Peripheral Guidewire
Manufacturer
Heraeus Medical Components, LLC
Date Cleared
2019-11-26
(173 days)
Product Code
DQX
Regulation Number
870.1330Why did this record match?
Applicant Name (Manufacturer) :
Heraeus Medical Components, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Intended to facilitate the placement of balloon dilation catheters during percutaneous transluminal angioplasty (PTA), in peripheral arteries including but not limited to femoral, popliteal arteries. This guide wire may also be used with compatible interventional devices during therapeutic procedures. The guide wire may also be used to reach and cross a target lesion, provide a pathway within the vessel structure, facilitate the substitution of one diagnostic or interventional device for another, and to distinguish the vasculature.
Device Description
The Heraeus Peripheral Guidewire is a guidewire constructed using a steel core with an optional nitinol alloy tip encapsulated by polymer and lubricious outer layer. The distal polymer includes a radiopaque loading, and the distal polymer section has a hydrophilic coating.
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K Number
K170664Device Name
Odyssey Micro Catheter
Manufacturer
Heraeus Medical Components, LLC
Date Cleared
2017-11-09
(248 days)
Product Code
DQY, DOY
Regulation Number
870.1250Why did this record match?
Applicant Name (Manufacturer) :
Heraeus Medical Components, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Odyssey Micro Catheter is intended to provide support to facilitate the placement of guidewires in the coronary and peripheral vasculatures and can be used to exchange one guide wire for another. The Odyssey Micro Catheter is also intended to assist in the infusion of contrast media. The micro catheter is not intended to be used in the neurovasculature.
Device Description
The Odyssey Micro Catheter is a single lumen catheter constructed using a PTFE liner inside of metallic coil and a polymer outer layer. The distal tip is a radiopaque polymer material and the distal 30 cm to 60 cm of the micro catheter has a hydrophilic coating. The key components of the catheter are the core, coil(s), tip, and coatings.
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K Number
K173052Device Name
Heraeus TMW Guidewire
Manufacturer
Heraeus Medical Components, LLC
Date Cleared
2017-10-20
(22 days)
Product Code
DQX
Regulation Number
870.1330Why did this record match?
Applicant Name (Manufacturer) :
Heraeus Medical Components, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Heraeus TMW Guidewire is intended to facilitate the introduction and placement of catheters and interventional devices during Percutaneous Transluminal Angioplasty (PTA) and/or Percutaneous Transluminal Coronary Angioplasty (PTCA).
Device Description
Heraeus TMW Guidewire is a steerable guidewire constructed of a bi-metal core wire. The distal core is made of Triton™ Nitinol alloy and has a coiled wire feature at the distal end. The proximal core is comprised of PTFE coated Stainless Steel material. The wire is available in .014" diameter and lengths ranging from 180 to 300 cm. The distal segment is coated with hydrophilic coating and is shapeable with a 3 cm radiopaque distal tip.
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