ISAAC Neurovascular Navigation Catheter

FDA 510(k) K261808 · Microvention Inc. d/b/a Terumo Neuro

Substantially Equivalent

510(k) numberK261808

Submission

Device name
ISAAC Neurovascular Navigation Catheter
Applicant
Microvention Inc. d/b/a Terumo Neuro
Aliso Viejo, CA, US
Received
June 1, 2026
Decision date
June 30, 2026
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
QJP – Catheter, Percutaneous, Neurovasculature
Device class
Class II (moderate risk)
Regulation
21 CFR 870.1250
Specialty
Cardiovascular

To provide vascular access to the neurovasculature for interventional or diagnostic procedures

Other 510(k)s with product code QJP

510(k)DeviceApplicantDecision
K26227770 NeuGlide CatheterQJP · Special Piraeus Medical, Inc.09/04/2026SE
K261176Zoom 4S CatheterQJP · Traditional Imperative Care, Inc.08/28/2026SE
K254071p17 XR MicrocatheterQJP · Traditional Wallaby Medical08/18/2026SE
K260199SLIM MicrocatheterQJP · Traditional Balt USA, LLC07/13/2026SE
K253901Millipede88 Access CatheterQJP · Traditional Perfuze, Ltd.07/09/2026SE
K261889Trevo Trak 21 MicrocatheterQJP · Special Stryker Neurovascular07/01/2026SE
K261549BOBBY Balloon Guide CatheterQJP · Special MicroVention, Inc., d/b/a Terumo Neuro06/09/2026SE
K253359Zenith Distal Access Long SheathQJP · Traditional Suzhou Zenith Vascular SciTech Limited05/22/2026SE
K254178SAYA 86 Radial Access Guide CatheterQJP · Traditional Asahi Intecc Co., Ltd.05/11/2026SE
K254046BosCATH Support CatheterQJP · Traditional Sonorous NV, Inc.04/21/2026SE

More from Sonorous NV, Inc.

510(k)DeviceDecision
K254035Mayumi™ Thrombectomy SystemQEZ · Traditional 09/03/2026SE
K261549BOBBY Balloon Guide CatheterQJP · Special 06/09/2026SE

Questions and answers

When was ISAAC Neurovascular Navigation Catheter cleared by the FDA?

ISAAC Neurovascular Navigation Catheter (K261808) received a 510(k) decision of Substantially Equivalent on June 30, 2026, 29 days after the submission was received.

What is the product code of K261808?

The FDA product code is QJP – Catheter, Percutaneous, Neurovasculature, a Class II (moderate risk) device regulated under 21 CFR 870.1250.