K210328

Substantially Equivalent

SafeSept Blunt Needle

Applicant: Pressure Products Medical Device Manufacturing, LLC
Product code: DRC
Advisory panel: Cardiovascular
Date received: 2021-02-04
Decision date: 2021-03-05
Decision: Substantially Equivalent
Clearance type: Special
Location: Morton, PA, US

Adverse events under product code DRC

product code DRC

Death: 28
Injury: 412
Total: 440

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.