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FDA 510(k)

ISAAC Neurovascular Navigation Catheter

K-Number: K261808 · 2026-06-30

ApplicantMicrovention Inc. d/b/a Terumo Neuro
Decision Date2026-06-30
Product CodeQJP
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

Other records listing Microvention Inc. d/b/a Terumo Neuro as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261549BOBBY Balloon Guide Catheter

Related Devices (Code: QJP)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260199SLIM MicrocatheterBalt USA, LLCK253901Millipede88 Access CatheterPerfuze, Ltd.K261889Trevo Trak 21 MicrocatheterStryker NeurovascularK261549BOBBY Balloon Guide CatheterMicroVention, Inc., d/b/a Terumo NeuroK253359Zenith Distal Access Long SheathSuzhou Zenith Vascular SciTech LimitedK254178SAYA 86 Radial Access Guide CatheterAsahi Intecc Co., Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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