510(k) Report

FDA applicant

MicroVention, Inc., d/b/a Terumo Neuro

Aliso Viejo, CA3 decisions2026–20260 recalls

FDA records 3 decisions for MicroVention, Inc., d/b/a Terumo Neuro (Aliso Viejo, CA) in 2026: 3 510(k) clearances. Most are in product codes QJP (Catheter, Percutaneous, Neurovasculature) and QEZ (Aspiration Thrombectomy Catheter). Since 2016 its 510(k)s took a median of 29 days from receipt to decision, against 141 for FDA’s reviews in the same codes and years. Its devices cite 3 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Microvention Inc. d/b/a Terumo Neuro”.

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 MicroVention, Inc., d/b/a Terumo Neuro’s devices, and how often a recall has named them.

FDA decisions per year

3in 2026

2026 (partial year): 3
2026high 3 (2026)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2026.

FIG. 1 — MicroVention, Inc., d/b/a Terumo Neuro by year, 2026–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like MicroVention, Inc., d/b/a Terumo Neuro’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

Which product codes does it file in?

  • QJPCatheter, Percutaneous, Neurovasculature2decisions
  • QEZAspiration Thrombectomy Catheter1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 29 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 141 days; 2 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K254035Mayumi™ Thrombectomy SystemMicroVention, Inc., d/b/a Terumo Neuro · 2026
  • K261808ISAAC Neurovascular Navigation CatheterMicrovention Inc. d/b/a Terumo Neuro · 2026
  • K261549BOBBY Balloon Guide CatheterMicroVention, Inc., d/b/a Terumo Neuro · 2026

All 2 as MicroVention, Inc., d/b/a Terumo Neuro →The one decision as Microvention Inc. d/b/a Terumo Neuro →

Other applicant names beginning “MicroVention”

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

MicroVention, Inc. 90MicroVention, Inc. A TERUMO Group Company 1