SAFEGUARD 24 CM PRESSURE ASSISTED DRESSING— 510(k) K062569

Substantially Equivalent

Datascope Corp.

FDA 510(k) clearance K062569 for SAFEGUARD 24 CM PRESSURE ASSISTED DRESSING, Substantially Equivalent on 2007-02-14. Applicant: Datascope Corp..

Clearance details

Applicant: Datascope Corp.
Product code: Code DXC
Advisory panel: Cardiovascular
Date received: 2006-08-31
Decision date: 2007-02-14
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Manwah, NJ, US

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Adverse events under product code DXC

product code DXC

Death: 14
Injury: 442
Malfunction: 2,209
Other: 1
Total: 2,666

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.