TATCH-IT— 510(k) K870356

Substantially Equivalent

Reunion Medical Co.

FDA 510(k) clearance K870356 for TATCH-IT, Substantially Equivalent on 1987-06-12. Applicant: Reunion Medical Co..

Clearance details

Applicant: Reunion Medical Co.
Product code: Code DRS
Advisory panel: Cardiovascular
Date received: 1987-01-29
Decision date: 1987-06-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lenexa, KS, 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.