FOCUS PC BALLOON DILATATION CATHETER— 510(k) K954313

Substantially Equivalent

Cardio-Dynamics, Inc.

FDA 510(k) clearance K954313 for FOCUS PC BALLOON DILATATION CATHETER, Substantially Equivalent on 1995-12-01. Applicant: Cardio-Dynamics, Inc..

Clearance details

Applicant: Cardio-Dynamics, Inc.
Product code: Code LIT
Advisory panel: Cardiovascular
Date received: 1995-09-15
Decision date: 1995-12-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

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Adverse events under product code LIT

product code LIT

Death: 27
Injury: 1,256
Malfunction: 12,127
Total: 13,410

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.