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AVIA VASCULAR

Matched from indexed company URL: AVIA Vascular

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30245378443024537844AVIA VASCULAR1N2026-01-01299 S Main St Ste 2300 Salt Lake City UT US 84111

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
0085004236501422G Open-System Ally Blood Collection Device - AV1100008017469453mpell@avia-vascular.com
0085004236505220G 8CM Stiletto Extended Dwell Catheter - 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.(801) 824-5375info@avia-vascular.com
1085004236505920G 8CM Stiletto Extended Dwell Catheter - 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.(801) 824-5375info@avia-vascular.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3099321154147281K22025820G Open-System Ally Device Kit (AV100000), 22G Open-System Ally Device Kit (AV110000)JKA2022-07-14

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
JKA12022-07-14

PMN#

GUDID#

20G 8CM Stiletto Extended Dwell Catheter - 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.

Avia Vascular, LLC

2024-06-25

20G 8CM Stiletto Extended Dwell Catheter - 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.

Avia Vascular, LLC

2024-06-25