Company · US
Pressure Products Medical Device Manufacturing, LLC
FDA 510(k) clearances and medical device recalls filed under this name, 2017 to 2026. Name variants (Inc, Corp, punctuation) are merged.
9510(k) clearances (1 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 13, 2026 | K253799 | SafeSept RF Transseptal Guidewire (SSRF132; SSRF132R; SSRF232; SSRF232R; SSRF135; SSRF135R; SSRF235; SSRF235R) Pressure Products Medical Device Manufacturing, LLC | DXF |
| May 17, 2024 | K241042 | SafeSharp Transseptal Needle (CLICK071, CLICK171, CLICK098, CLICK198) Pressure Products Medical Device Manufacturing, LLC | DRC |
| Sep 14, 2022 | K221707 | SafeSept® Transseptal Guidewire (SS-140) Pressure Products Medical Device Manufacturing, LLC | DRC |
| Mar 5, 2021 | K210328 | SafeSept Blunt Needle Pressure Products Medical Device Manufacturing, LLC | DRC |
| Oct 26, 2018 | K181031 | TSI Transseptal Introducer Pressure Products Medical Device Manufacturing, LLC | DYB |
| Feb 21, 2018 | K172950 | TSN Transseptal Needle Pressure Products Medical Device Manufacturing, LLC | DRC |
| Feb 16, 2018 | K172934 | Needle Free Transseptal Cannula Pressure Products Medical Device Manufacturing, LLC | DRC |
| Dec 21, 2017 | K172893 | SafeSept Needle Free Transseptal Guidewire Pressure Products Medical Device Manufacturing, LLC | DRC |
| Oct 20, 2017 | K170671 | SafeSept Transseptal Guidewire Pressure Products Medical Device Manufacturing, LLC | DRC |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||