Pressure Products Medical Device Manufacturing, LLC
FDA 510(k) & PMA Approved Devices — 9 products
Total Devices9
Categories3
Latest Approval2026-03-13
| Type | Number | Device Name | Code | Date | |
|---|---|---|---|---|---|
| 510(k) | K253799 | SafeSept RF Transseptal Guidewire (SSRF132; SSRF132R; SSRF232; SSRF232R; SSRF135; SSRF135R; SSRF235; SSRF235R) | DXF | 2026-03-13 | View |
| 510(k) | K241042 | SafeSharp Transseptal Needle (CLICK071, CLICK171, CLICK098, CLICK198) | DRC | 2024-05-17 | View |
| 510(k) | K221707 | SafeSept® Transseptal Guidewire (SS-140) | DRC | 2022-09-14 | View |
| 510(k) | K210328 | SafeSept Blunt Needle | DRC | 2021-03-05 | View |
| 510(k) | K181031 | TSI Transseptal Introducer | DYB | 2018-10-26 | View |
| 510(k) | K172950 | TSN Transseptal Needle | DRC | 2018-02-21 | View |
| 510(k) | K172934 | Needle Free Transseptal Cannula | DRC | 2018-02-16 | View |
| 510(k) | K172893 | SafeSept Needle Free Transseptal Guidewire | DRC | 2017-12-21 | View |
| 510(k) | K170671 | SafeSept Transseptal Guidewire | DRC | 2017-10-20 | View |
No matching devices.