Innova Vascular, Inc.

FDA Device Registration & Listing · Irvine, CA, US · Registration 3020256033

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
3020256033
FEI Number
3020256033
Entity Name
Innova Vascular, Inc.
City/State/Country
Irvine, CA, US
Establishment Address
15375 Barranca Parkway, B-101, Irvine, CA 92618, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Innova Vascular, Inc. (Owner Number: 10088280)
Owner / Operator Contact Address
15375 Barranca Parkway, B-101, Irvine, CA 92618, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K223929
PMA Number
N/A

All Registered Proprietary Names

Laguna Clot Retriever™ System Malibu Aspiration Catheter™ System

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
QEW Peripheral Mechanical Thrombectomy With Aspiration Cardiovascular Class 2 870.5150 2023-06-23
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2023-06-23

Official Correspondent

Ryan Kenney

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Innova Vascular, Inc.
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
K241362 Surmodics,Inc. Pounce XL Thrombectomy System (PTS-1011-7F135) 2024-09-11
K220887 Inari Medical Mini-ClotTriever Thrombectomy System 2022-08-04
K250421 Inari Medical, Inc. InThrill™ Thrombectomy System 2025-05-12
K192036 Inari Medical ClotTriever Thrombectomy System 2019-08-29
K792141 Pharmaseal Div., Baxter Healthcare Corp. CONTINUOUS FLUSH DEVICE 1979-12-05

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3020256033. Last updated year: 2026. Please use registration number 3020256033 when referencing this establishment in official correspondence.
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