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510(k) Data Aggregation
K Number
K213550Device Name
HydroPICC 5F Dual Lumen Catheter
Manufacturer
Access Vascular Inc
Date Cleared
2022-05-04
(177 days)
Product Code
LJS
Regulation Number
880.5970Why did this record match?
Applicant Name (Manufacturer) :
Access Vascular Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Indicated for short-or long-term peripheral access to the central venous therapy, including but not limited to the administration of fluids, medications, and nutrients; the sampling of blood; central venous pressure monitoring; and power injection of contrast media.
Rated for maximum power injection flow rate of 3.5ml/s
Device Description
The HydroPICC peripherally inserted central catheter (PICC) is a 5 French, dual lumen catheter comprised of a radiopaque hydrophilic catheter material with a suture wing, Luer lock hubs, and extension tubes made from materials commonly used in the manufacture of catheters are provided packaged in kit configurations with the appropriate accessories for placement in the appropriate clinical environments. The maximum power injection flow rate for each lumen is indicated on each extension tube clamp.
HydroPICC has been shown to be effective in reducing thrombus accumulation. Reduction of thrombus accumulation was evaluated using in vivo models. Pre-clinical in vitro and in vivo evaluations do not necessarily predict clinical performance with respect to thrombus formation.
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K Number
K203069Device Name
HydroMID
Manufacturer
Access Vascular Inc.
Date Cleared
2021-02-08
(122 days)
Product Code
FOZ
Regulation Number
880.5200Why did this record match?
Applicant Name (Manufacturer) :
Access Vascular Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The HydroMID is indicated for short term access (<30days) to the peripheral venous access system for intravenous therapy, including but not limited to, the administrations, and the sampling of blood and blood products. Therapies not appropriate for midline catheters include continuous vesicant therapy, parenteral nutrition, infusates with pH less than 5 or greater than 9, and infusates with an osmolarity greater than 600mOsm/L.
HydroMID is rated for a Maximum Power Injection Flow Rate of 6mL/sec.
Device Description
The HydroMID catheter is a short term (< 30 days) peripheral venous access device with a single 4F outer diameter lumen that is 20 cm in length. Midlines are usually placed in an arm vein such as the basilic, brachial, or cephalic and the tip ends below the level of the axillary line. Midline catheters are longer than peripheral IV catheters which are generally 1 to 3 inches long and shorter than peripherally inserted central catheters (PICC) which extend into the superior vena cava. This device provides an alternative to short peripheral IVs and PICCs for certain treatments.
The HydroMID catheter is comprised of radiopaque, hydrophilic base with a suture wing, Luer lock hub, and extension tube made from materials commonly used in the manufacture of catheters. The catheter has a maximum power injection flow rate of 6ml/sec. HydroMID has been shown to be effective in reducing thrombus accumulation. Reduction of thrombus accumulation was evaluated using in vitro and in vivo models. Pre-clinical in vitro and in vivo evaluations do not necessarily predict clinical performance with respect to thrombus formation.
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