CARDIOVENTION CORX IOS-200 SYSTEM, MODEL IOS-200— 510(k) K032068

Substantially Equivalent

Cardiovention, Inc.

FDA 510(k) clearance K032068 for CARDIOVENTION CORX IOS-200 SYSTEM, MODEL IOS-200, Substantially Equivalent on 2003-08-22. Applicant: Cardiovention, Inc..

Clearance details

Applicant: Cardiovention, Inc.
Product code: Code DTR
Advisory panel: Cardiovascular
Date received: 2003-07-03
Decision date: 2003-08-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Clara, CA, US

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Adverse events under product code DTR

product code DTR

Other: 1
Total: 1

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.