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.
Clearance details
- Applicant
- MicroVention, Inc., d/b/a Terumo Neuro
- Product code
- Code QJP
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Aliso Viejo, CA, US
Adverse 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.