510(k) K024000— METRICATH SYSTEM COMPRISED OF METRICATH 1000 CONSOLE & METRICATH BALLOON CATHETER

Substantially Equivalent

Angiometrx, Inc.

Clearance details

Applicant: Angiometrx, Inc.
Product code: Code DQO
Advisory panel: Cardiovascular
Date received: 2002-12-04
Decision date: 2003-06-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seattle, WA, 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.