SafeSept Blunt Needle— 510(k) K210328
Substantially EquivalentPressure Products Medical Device Manufacturing, LLC
FDA 510(k) clearance K210328 for SafeSept Blunt Needle, Substantially Equivalent on 2021-03-05. Applicant: Pressure Products Medical Device Manufacturing, LLC. Device class: 2.
Clearance details
- Applicant
- Pressure Products Medical Device Manufacturing, LLC
- Product code
- Code DRC
- Device class
- Class 2
- Regulation
- 21 CFR 870.1390
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Morton, PA, US
Recent devices under product code DRC
view allMore clearances from Pressure Products Medical Device Manufacturing, LLC
view allAdverse events under product code DRC
product code DRC- Death
- 28
- Injury
- 412
- Total
- 440
Source: openFDA MAUDE database, through . 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.