510(k) K012749— BIOCARDIA UNIVERSAL DEFLECTABLE GUIDE CATHETER, MODEL 000664

Substantially Equivalent

Biocardia, Inc.

Clearance details

Applicant: Biocardia, Inc.
Product code: Code DQO
Advisory panel: Cardiovascular
Date received: 2001-08-16
Decision date: 2002-01-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: South San Francisco, CA, US

Adverse events under product code DQO

product code DQO

Death: 35
Injury: 993
Malfunction: 1,772
Other: 5
Total: 2,805

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.