ALTAVIZ, LLC

FDA Device Registration & Listing · Irvine, CA, US · Registration 3013633270

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3013633270
FEI Number
3013633270
Entity Name
ALTAVIZ, LLC
City/State/Country
Irvine, CA, US
Establishment Address
13766 Alton Parkway, Suite 143, Irvine, CA 92618, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
Altaviz, LLC (Owner Number: 10086745)
Owner / Operator Contact Address
13766 Alton Parkway, Suite 143, Irvine, CA 92618, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K231261
PMA Number
N/A

All Registered Proprietary Names

Injection Kit Injection Kit

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FMI Needle, Hypodermic, Single Lumen General Hospital Class 2 880.5570 2022-12-07
GAA Needle, Aspiration And Injection, Disposable General, Plastic Surgery Class 1 878.4800 2022-12-07
GAA Needle, Aspiration And Injection, Disposable General, Plastic Surgery Class 1 878.4800 2023-09-14
FMI Needle, Hypodermic, Single Lumen General Hospital Class 2 880.5570 2023-09-14

Official Correspondent

Gary Holland

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Altaviz, LLC
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
K812404 Nu Tech Medical Systems BUTTERFLY NEEDLE ASSEMBLY 1981-09-09
K781371 Ferris Mfg. Corp. BONE MARROW ASPIRATION KIT 1978-09-20

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0002-2022 Bard Peripheral Vascular Inc 2
REF TIN3015, 15G x 79 mm Bone Marrow Aspiration/Intraosseous Infusion Needle, For Single Use Only, Sterile EO, UDI: 10885403043796
Z-0017-2023 Hobbs Medical, Inc. 1
Hobbs Transbronchial Aspiration Needle and Vacu-lok Aspirating Syringe Catalog Number: 4620
Z-0018-2023 Hobbs Medical, Inc. 1
Hobbs Transbronchial Aspiration Needle Catalog Number: 4621
Z-0023-2011 Becton Dickinson & Company 1
BD 30G1/2 PrecisionGlide Needle;Catalog/Lot Number: 305106. Needles are intended for use in aspiration and injection of medications.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013633270. Last updated year: 2026. Please use registration number 3013633270 when referencing this establishment in official correspondence.
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