Pressure Products Medical Device Manufacturing, LLC
Active in EUDAMEDUnited Statesfrom SRN EUDAMED SRN US-MF-000013696
- Devices
- 9
- Registrations
- EUDAMED
At a glance
Market reach
- European Union
- EUDAMED actor
- Authorised rep.
- Bisping Medizintechnik GmbHDE
What Pressure Products Medical Device Manufacturing, LLC makes
Pressure Products Medical Device Manufacturing, LLC produces transseptal devices for cardiac procedures, including introducers, guidewires, blunt needles, cannulas, and transseptal needles. These products are designed for accessing the left atrium via the interatrial septum, supporting interventions like ablation and structural heart repairs. The portfolio includes both active and passive devices, such as RF-guided and needle-free systems.
The company’s devices are classified under Class II and Class III regulatory categories, with some listed in the EUDAMED database and others subject to FDA 510(k) clearance. The manufacturer is based in the United States.
Catalogue
TSI Transseptal Introducer Ref K181031
Regimes: 510(k) Registry: 510(k)- Regimes: CE MDD 510(k) Registry: 510(k)
SafeSept Blunt Needle Ref K210328
Regimes: 510(k) Registry: 510(k)SafeSept® Transseptal Guidewire (SS-140) Ref K221707
Regimes: 510(k) Registry: 510(k)Needle Free Transseptal Cannula Ref K172934
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
TSN Transseptal Needle Ref K172950
Regimes: 510(k) Registry: 510(k)SafeSept Needle Free Transseptal Guidewire Ref K172893
Regimes: 510(k) Registry: 510(k)SafeSept Transseptal Guidewire Ref SS-135
Regimes: CE MDD 510(k) Registry: EUDAMEDGUDID
Company details
- EUDAMED SRN
- US-MF-000013696
- EUDAMED status
- Active
- EUDAMED registered name
- Pressure Products Medical Device Manufacturing LLC.
- EUDAMED abbreviated name
- PPMDM
- Registered address
- 1, School Street, 19070, Morton, United States
- [email protected]
- PRRC contact
- Rania deLeon
Frequently asked questions
How many devices does Pressure Products Medical Device Manufacturing, LLC have in the registry?
The registry currently lists 9 devices for Pressure Products Medical Device Manufacturing, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Pressure Products Medical Device Manufacturing, LLC's devices?
Among its 9 most recently registered devices, Pressure Products Medical Device Manufacturing, LLC has devices listed in EUDAMED (1 device), FDA 510(k) (8 devices) and FDA GUDID (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Pressure Products Medical Device Manufacturing, LLC's devices fall under?
Among its 9 most recently registered devices, the classes recorded for Pressure Products Medical Device Manufacturing, LLC's devices are Class II and Class III. Each device page shows its own class and authorisation.
What are the newest devices from Pressure Products Medical Device Manufacturing, LLC in the registry?
The most recently registered devices listed for Pressure Products Medical Device Manufacturing, LLC include TSI Transseptal Introducer, SafeSept RF Transseptal Guidewire (SSRF132; SSRF132R; SSRF232; SSRF232R; SSRF135; SSRF135R; SSRF235; SSRF235R), SafeSept Blunt Needle and SafeSept® Transseptal Guidewire (SS-140).