Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3024537844

FEI Number

3024537844

Entity Name

AVIA VASCULAR

City/State/Country

Salt Lake City, UT, US

Establishment Address

299 S Main St Ste 2300, Salt Lake City, UT 84111, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Avia Vascular (Owner Number: 10086184)

Owner / Operator Contact Address

299 South Main Street, Suite 2375, Salt Lake City, UT 84111, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K220258

PMA Number

N/A

All Registered Proprietary Names

Ally Blood Collection Device

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2022-10-20

Official Correspondent

Kevin Cook

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Avia Vascular

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K945777	Smiths Industries Medical Systems, Inc.	PRO-VENT(TM), PULSATOR(R), AND LINE DRAW(TM) ARTERIAL BLOOD SAMPLING SYRINGES	1994-12-22

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0030-2014	Perkin Elmer Health Sciences, Inc.	2	Perkin Elmer 226 Sample Collection Device, Serial numbers: 06132903 - 06198900. The PerkinElmer 226 Sample Collection Devices are intended to be used as a medium to collect and transport whole blood specimen spots to a laboratory, in newborn screening. The device includes a tear-apart form for the collection of demographic information.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3024537844. Last updated year: 2026. Please use registration number 3024537844 when referencing this establishment in official correspondence.