BOBBY Balloon Guide Catheter— 510(k) K261549
Substantially EquivalentMicroVention, Inc., d/b/a Terumo Neuro
FDA 510(k) clearance K261549 for BOBBY Balloon Guide Catheter, Substantially Equivalent on 2026-06-09. Applicant: MicroVention, Inc., d/b/a Terumo Neuro. Device class: 2.
Summary
The BOBBY Balloon Guide Catheter is from MicroVention, doing business as Terumo Neuro, and is filed under QJP, percutaneous neurovasculature catheters. The record gives no sizes.
Class II, 21 CFR 870.1250. The Neurology review panel handled it as a Special 510(k), though the record lists Cardiovascular as the classification panel.
MicroVention filed from Aliso Viejo, California. The decision came 29 calendar days after receipt (May 11 to June 9, 2026).
Clearance details
- Applicant
- MicroVention, Inc., d/b/a Terumo Neuro
- Product code
- Product code QJP
- Device class
- Class 2
- Regulation
- 21 CFR 870.1250
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Aliso Viejo, CA, US
Recent devices under product code QJP
view allMore clearances from MicroVention, Inc., d/b/a Terumo Neuro
view allAdverse events under product code QJP
product code QJP- Death
- 43
- Injury
- 233
- Malfunction
- 1,010
- Total
- 1,286
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.