FDA device listing
ASCENDRA BALLOON AORTIC VALVULOPLASTY CATHETER,Ascendra + Delivery System,ASCENDRA+ DELIVERY SYSTEM WITH CRIMP…
FDA device listing 1218721214 · Sotera Health LLC
Key facts
| Proprietary names | ASCENDRA BALLOON AORTIC VALVULOPLASTY CATHETER,Ascendra + Delivery System,ASCENDRA+ DELIVERY SYSTEM WITH CRIMP STOPPER,ASCENDRA+ INTRODUCER SHEATH SET,Ascendra + System,CRIMPER,Crimp Stopper,Edwards Crimper Ascendra + Introducer Sheath Set,Edwards Dilator Kit,Edwards Expandable Introducer Sheath Set,EDWARDS EXPANDABLE INTRODUCER SHEATH SET,Edwards SAPIEN XT Transcatheter Heart Valve,EDWARDS SAPIEN… |
|---|---|
| Owner/operator | Sotera Health LLC |
| Owner/operator number | 10029425 |
| Product codes | NPT |
| Device names | NPT - Aortic Valve, Prosthesis, Percutaneously Delivered |
| Device class | Class III |
| Classification regulations (21 CFR) | ORCA1.NPT |
| Review panels | Cardiovascular |
| Registered establishments | Sterigenics U.S., LLC, Sterigenics US LLC |
| Establishment registrations | 1721676, 2011171 |
| FEI numbers | 1721676, 2011171 |
| Establishment operations | Contract Sterilizer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database