CARDIOVENTION POWERBASE CONSOLE, MODEL PBC-100— 510(k) K021694

Substantially Equivalent

Cardiovention, Inc.

FDA 510(k) clearance K021694 for CARDIOVENTION POWERBASE CONSOLE, MODEL PBC-100, Substantially Equivalent on 2003-01-08. Applicant: Cardiovention, Inc..

Clearance details

Applicant: Cardiovention, Inc.
Product code: Code DTQ
Advisory panel: Cardiovascular
Date received: 2002-05-22
Decision date: 2003-01-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Clara, CA, US

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Adverse events under product code DTQ

product code DTQ

Death: 123
Malfunction: 4,822
Other: 1
Total: 4,946

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.