SafeSharp Transseptal Needle (CLICK071, CLICK171, CLICK098, CLICK198)— 510(k) K241042
Substantially EquivalentPressure Products Medical Device Manufacturing, LLC
FDA 510(k) clearance K241042 for SafeSharp Transseptal Needle (CLICK071, CLICK171, CLICK098, CLICK198), Substantially Equivalent on 2024-05-17. 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.