DeviceClearance

K193607

Substantially Equivalent

BOBBY Balloon Guide Catheter

Applicant
MicroVention, Inc.
Product code
DQY
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Aliso Viejo, CA, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code DQY

product code DQY
Death
464
Injury
4,489
Malfunction
13,721
Other
2
Total
18,676

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.