Data / Medical devices / United States / Pressure Products Medical Device Manufacturing LLC
Pressure Products Medical Device Manufacturing LLC: FDA-registered device maker in Morton, PA, United States, 9 510(k) clearances
Pressure Products Medical Device Manufacturing LLC is registered with the FDA (registration 3013986346) in Morton, PA, United States. It lists 5 device types. The FDA files 9 510(k) clearances under its listings, the newest dated March 13, 2026. Registered through 2027. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3013986346
- Address
- 1 School Street, Morton, PA, United States, 19070
- Owner or operator
- Pressure Products Medical Device Manufacturing LLC (10052778)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- October 23, 2017
- Registered through
- 2027
- Brand names listed
- HEMOBILIZER, HOLD DEVICE, Needle Free Transseptal Cannula, POCKET PAL, SafeSept Blunt Needle, SafeSept Needle Free Transseptal Guidewire, SafeSept RF Transseptal Guidewire, SafeSept Transseptal Guidewire and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bandage, Elastic | FQM | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Catheter, Septostomy | DXF | 2 | Manufacturer | accessdata.fda.gov |
| Introducer, Catheter | DYB | 2 | Manufacturer | accessdata.fda.gov |
| Orthosis, Limb Brace | IQI | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Trocar | DRC | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 13, 2026 | K253799 | SafeSept RF Transseptal Guidewire (SSRF132; SSRF132R; SSRF232; SSRF232R; SSRF135; SSRF135R; SSRF235; SSRF235R) | DXF | Substantially Equivalent | Pressure Products Medical Device Manufacturing, LLC | accessdata.fda.gov |
| May 17, 2024 | K241042 | SafeSharp Transseptal Needle (CLICK071, CLICK171, CLICK098, CLICK198) | DRC | Substantially Equivalent | Pressure Products Medical Device Manufacturing, LLC | accessdata.fda.gov |
| September 14, 2022 | K221707 | SafeSept® Transseptal Guidewire (SS-140) | DRC | Substantially Equivalent | Pressure Products Medical Device Manufacturing, LLC | accessdata.fda.gov |
| March 5, 2021 | K210328 | SafeSept Blunt Needle | DRC | Substantially Equivalent | Pressure Products Medical Device Manufacturing, LLC | accessdata.fda.gov |
| October 26, 2018 | K181031 | TSI Transseptal Introducer | DYB | Substantially Equivalent | Pressure Products Medical Device Manufacturing, LLC | accessdata.fda.gov |
| February 21, 2018 | K172950 | TSN Transseptal Needle | DRC | Substantially Equivalent | Pressure Products Medical Device Manufacturing, LLC | accessdata.fda.gov |
| February 16, 2018 | K172934 | Needle Free Transseptal Cannula | DRC | Substantially Equivalent | Pressure Products Medical Device Manufacturing, LLC | accessdata.fda.gov |
| December 21, 2017 | K172893 | SafeSept Needle Free Transseptal Guidewire | DRC | Substantially Equivalent | Pressure Products Medical Device Manufacturing, LLC | accessdata.fda.gov |
| October 20, 2017 | K170671 | SafeSept Transseptal Guidewire | DRC | Substantially Equivalent | Pressure Products Medical Device Manufacturing, LLC | accessdata.fda.gov |
Compare with other makers
- All makers of Bandage, Elastic
- All makers of Trocar
- All makers of Catheter, Septostomy
- All makers of Orthosis, Limb Brace
- All makers of Introducer, Catheter
Updated March 13, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.