DISPOSABLE FLUSH DEVICE— 510(k) K860681

Substantially Equivalent

Hewlett-Packard Co.

FDA 510(k) clearance K860681 for DISPOSABLE FLUSH DEVICE, Substantially Equivalent on 1986-06-17. Applicant: Hewlett-Packard Co..

Clearance details

Applicant: Hewlett-Packard Co.
Product code: Code DRS
Advisory panel: Cardiovascular
Date received: 1986-02-25
Decision date: 1986-06-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Andover, MA, 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.