PPG BIOMEDICAL FLEXIBLE MICRO TRANSDUCER CATHETER— 510(k) K894286

Substantially Equivalent

Ppg Industries, Inc.

FDA 510(k) clearance K894286 for PPG BIOMEDICAL FLEXIBLE MICRO TRANSDUCER CATHETER, Substantially Equivalent on 1989-10-12. Applicant: Ppg Industries, Inc..

Clearance details

Applicant: Ppg Industries, Inc.
Product code: Code DXO
Advisory panel: Cardiovascular
Date received: 1989-06-23
Decision date: 1989-10-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pleasantville, NY, US

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Adverse events under product code DXO

product code DXO

Death: 10
Injury: 156
Malfunction: 884
Total: 1,050

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.