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510(k) Data Aggregation
K Number
K251376Device Name
LimFlow ARC
Manufacturer
LimFlow Inc.
Date Cleared
2025-05-31
(29 days)
Product Code
PDU
Regulation Number
870.1250Why did this record match?
Applicant Name (Manufacturer) :
LimFlow Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The LimFlow ARC is intended to facilitate placement and positioning of guide wires and catheters within the peripheral vasculature. The LimFlow ARC is not intended for use in the coronary or cerebral vasculature.
Device Description
The LimFlow ARC is a single-use device designed to facilitate placement and positioning of guide wires within the peripheral vasculature. The device consists of three primary elements: 1) Cannula, 2) Catheter shaft, and 3) Deployment handle with deployment control slide. The LimFlow ARC is used in a healthcare facility, such as a cardiac catheter lab or hospital. It is in contact with patient tissue for less than 24 hours and is made of materials that are biocompatible. The LimFlow ARC is supplied sterile.
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K Number
K242776Device Name
LimFlow V-Ceiver
Manufacturer
LimFlow Inc.
Date Cleared
2025-02-14
(154 days)
Product Code
MMX
Regulation Number
870.5150Why did this record match?
Applicant Name (Manufacturer) :
LimFlow Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The LimFlow V-Ceiver is intended for use in the cardiovascular system to manipulate and retrieve guidewires specified in the IFU.
Device Description
The LimFlow V-Ceiver is a percutaneous snaring device with a luer on the proximal end and a snaring basket at the distal end. The basket is composed of nitinol for shape memory and visibility with radiopaque markers on either end of the basket for added visibility. The coaxial sheathing system is used to re-constrain the basket once a guide wire is captured.
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K Number
K222083Device Name
LimFlow V-Ceiver
Manufacturer
LimFlow Inc.
Date Cleared
2022-08-09
(25 days)
Product Code
MMX
Regulation Number
870.5150Why did this record match?
Applicant Name (Manufacturer) :
LimFlow Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The LimFlow V-Ceiver™ is intended for use in the cardiovascular system to manipulate and retrieve guidewires specified in the IFU.
Device Description
The LimFlow V-Ceiver consists of an intravascular catheter which incorporates a nitinol basket (the "Snare") at its distal tip. The nitinol basket has an outer diameter of 6 mm. The catheter has a built-in coaxial sheathing system and incorporates radiopaque markers at the distal tip on either end of the basket for added visibility. The catheter if compatible with 4 Fr introducer sheaths and has a working length of 100 cm.
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