FDA device listing
Flextome Cutting Balloon Microsurgical Dilatation Device,Wolverine Coronary Cutting Balloon Microsurgical Dilatation…
FDA device listing 1352338383 · Boston Scientific Corporation
Key facts
| Proprietary names | Flextome Cutting Balloon Microsurgical Dilatation Device,Wolverine Coronary Cutting Balloon Microsurgical Dilatation Device |
|---|---|
| Owner/operator | Boston Scientific Corporation |
| Owner/operator number | 9912058 |
| Premarket submissions | P950020 |
| Product codes | LIT, LOX, MAF, NIN, NIQ, NWX |
| Device names | LIT - Catheter, Angioplasty, Peripheral, Transluminal, LOX - Catheters, Transluminal Coronary Angioplasty, Percutaneous, MAF - Stent, Coronary, NIN - Stent, Renal, NIQ - Coronary Drug-Eluting Stent, NWX - Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring |
| Device class | Class II, Class III |
| Classification regulations (21 CFR) | 870.1250, 870.5100, ORCA1.MAF, ORCA1.NIN, ORCA1.NIQ, ORCA1.NWX |
| Review panels | Cardiovascular |
| Registered establishments | Boston Scientific Corporation, Boston Scientific Limited |
| Establishment registrations | 2124215, 9681260, 1000121056 |
| FEI numbers | 2124215, 1000121056, 3002806565 |
| Establishment operations | Complaint File Establishment, Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 100–999 UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes 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