FDA 510(k)

ISAAC Neurovascular Navigation Catheter

Número K: K261808 · 2026-06-30

RequerenteMicrovention Inc. d/b/a Terumo Neuro

Data da decisão2026-06-30

Código do produtoQJP

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

ISAAC Neurovascular Navigation Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Microvention Inc. d/b/a Terumo Neuro. It received FDA 510(k) clearance on 2026-06-30 under 510(k) number K261808. The device is classified under product code QJP. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the ISAAC Neurovascular Navigation Catheter?

ISAAC Neurovascular Navigation Catheter is a medical device that received FDA 510(k) clearance on 2026-06-30. The listed applicant is Microvention Inc. d/b/a Terumo Neuro. The 510(k) number is K261808.

When did ISAAC Neurovascular Navigation Catheter receive FDA 510(k) clearance?

ISAAC Neurovascular Navigation Catheter received FDA 510(k) clearance on 2026-06-30, under 510(k) number K261808.

Who is the listed applicant for ISAAC Neurovascular Navigation Catheter?

The FDA 510(k) record lists Microvention Inc. d/b/a Terumo Neuro as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ISAAC Neurovascular Navigation Catheter?

The FDA product code for ISAAC Neurovascular Navigation Catheter is QJP.

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Fonte oficial

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