FDA applicant

Innova Vascular, Inc.

Irvine, CA1 decision2023–20230 recalls

FDA records 1 decision for Innova Vascular, Inc. (Irvine, CA) in 2023: 1 510(k) clearance. All are in product code QEW (Peripheral Mechanical Thrombectomy With…). Its devices cite 1 predicate, 0 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Innova Vascular, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2023high 1 (2023) · low 0 (2024)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2023.

FIG. 1 — Innova Vascular, Inc. by year, 2023–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Innova Vascular, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Other applicant names beginning “Innova”

FDA records each applicant name separately; these may or may not be the same firm.

Innova Vision, Inc. 11 Innova Corp. 6 Innova Life Sciences Corp. 4 Innova Spinal Technologies, LLC 2

Innova Vascular, Inc.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Innova”