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FDA 510(k)

BOBBY Balloon Guide Catheter

K-Number: K261549 · 2026-06-09

ApplicantMicroVention, Inc., d/b/a Terumo Neuro
Decision Date2026-06-09
Product CodeQJP
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BOBBY Balloon Guide 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 2026-06-09 under 510(k) number K261549. 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 BOBBY Balloon Guide Catheter?

BOBBY Balloon Guide Catheter is a medical device that received FDA 510(k) clearance on 2026-06-09. The listed applicant is MicroVention, Inc., d/b/a Terumo Neuro. The 510(k) number is K261549.

When did BOBBY Balloon Guide Catheter receive FDA 510(k) clearance?

BOBBY Balloon Guide Catheter received FDA 510(k) clearance on 2026-06-09, under 510(k) number K261549.

Who is the listed applicant for BOBBY Balloon Guide 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 BOBBY Balloon Guide Catheter?

The FDA product code for BOBBY Balloon Guide Catheter is QJP.

Related Clinical Trials

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.

NCT07247864Balloon Guide Catheter Combined With Filter Protection for Carotid Artery StentingRECRUITINGNCT07576790Evaluation of Balloon Guide Catheter as Proximal Protection During Carotid Artery Stenting (EMBO-PROTECT)NOT_YET_RECRUITINGNCT07678164A Randomized Trial of Carotid Artery Stenting With Balloon Guide CatheterNOT_YET_RECRUITING

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.

K261808ISAAC Neurovascular Navigation 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 NeurovascularK261808ISAAC Neurovascular Navigation 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

View on FDA Database →

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

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