510(k) Report

FDA applicant

Endovascular Engineering

Menlo Park, CA4 decisions2023–20260 recalls

FDA records 4 decisions for Endovascular Engineering (Menlo Park, CA) from 2023 to 2026: 4 510(k) clearances. Most are in product codes QEW (Peripheral Mechanical Thrombectomy With…) and SHJ (Thrombectomy Whole Blood Return System). Since 2016 its 510(k)s took a median of 93 days from receipt to decision, against 74 for FDA’s reviews in the same codes and years. Its devices cite 5 predicates, 2 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Endovascular Engineering, Inc.”.

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 Endovascular Engineering’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2023: 12025: 12026 (partial year): 2
2023high 2 (2026) · low 0 (2024)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2023.

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

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Which product codes does it file in?

  • QEWPeripheral Mechanical Thrombectomy With Aspiration3decisions
  • SHJThrombectomy Whole Blood Return System1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 93 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 74 days; 1 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 5 predicates; 2 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K223891Cobra Catheter SystemEndovascular Engineering · 20231cites it
  • K252956Helo Thrombectomy SystemEndovascular Engineering, Inc. · 20251cites it

What has FDA decided for it lately?

  • K253717Helo™ ReturnEndovascular Engineering, Inc. · 2026
  • K261800Helo Max Thrombectomy System (HEL2090)Endovascular Engineering · 2026
  • K252956Helo Thrombectomy SystemEndovascular Engineering, Inc. · 2025
  • K223891Cobra Catheter SystemEndovascular Engineering · 2023

All 2 as Endovascular Engineering →All 2 as Endovascular Engineering, Inc. →

Other applicant names beginning “Endovascular”

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

Endovascular, Inc. 3Endovascular Instruments, Inc. 1