BOBBY Balloon Guide Catheter

FDA 510(k) K261549 · MicroVention, Inc., d/b/a Terumo Neuro

Substantially Equivalent

510(k) numberK261549

Submission

Device name
BOBBY Balloon Guide Catheter
Applicant
MicroVention, Inc., d/b/a Terumo Neuro
Aliso Viejo, CA, US
Received
May 11, 2026
Decision date
June 9, 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

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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
K261808ISAAC Neurovascular Navigation CatheterQJP · Special Microvention Inc. d/b/a Terumo Neuro06/30/2026SE
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.

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Questions and answers

When was BOBBY Balloon Guide Catheter cleared by the FDA?

BOBBY Balloon Guide Catheter (K261549) received a 510(k) decision of Substantially Equivalent on June 9, 2026, 29 days after the submission was received.

What is the product code of K261549?

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