FDA device listing
AngioSculpt PTCA Scoring Balloon Catheter,AngioSculpt PTCA Scoring Balloon Catheter - Easy Exchange (EX),AngioSculpt…
FDA device listing 1393140147 · Sotera Health LLC
Key facts
| Proprietary names | AngioSculpt PTCA Scoring Balloon Catheter,AngioSculpt PTCA Scoring Balloon Catheter - Easy Exchange (EX),AngioSculpt PTCA Scoring Balloon Catheter - Over-the-Wire (OTW),AngioSculpt PTCA Scoring Balloon Catheter - Rapid Exchange (RX),Catheter percutaneous transluminal coronary angioplasty PTCA cutting/scoring AngioSculpt PTCA Scoring Balloon Catheter |
|---|---|
| Owner/operator | Sotera Health LLC |
| Owner/operator number | 10029425 |
| Product codes | NWX |
| Device names | NWX - Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring |
| Device class | Class III |
| Classification regulations (21 CFR) | ORCA1.NWX |
| 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