TRANTEC DISPOSABLE PRESSURE TRANS.53-600/F/F30— 510(k) K872596

Substantially Equivalent

American Edwards Laboratories

FDA 510(k) clearance K872596 for TRANTEC DISPOSABLE PRESSURE TRANS.53-600/F/F30, Substantially Equivalent on 1987-09-30. Applicant: American Edwards Laboratories.

Clearance details

Applicant: American Edwards Laboratories
Product code: Code DRS
Advisory panel: Cardiovascular
Date received: 1987-07-02
Decision date: 1987-09-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Ana, CA, US

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Adverse events under product code DRS

product code DRS

Death: 8
Malfunction: 776
Total: 784

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.