FDA device listing
PowerWire Radiofrequency GuideWire,PowerWire Radiofrequency GuideWire Kit
FDA device listing 1943015122 · Baylis Medical Technologies Inc.
Key facts
| Proprietary names | PowerWire Radiofrequency GuideWire,PowerWire Radiofrequency GuideWire Kit |
|---|---|
| Owner/operator | Baylis Medical Technologies Inc. |
| Owner/operator number | 10082721 |
| Premarket submissions | K101615 |
| Product codes | PDU |
| Device names | PDU - Catheter For Crossing Total Occlusions |
| Device class | Class II |
| Classification regulations (21 CFR) | 870.1250 |
| Review panels | Cardiovascular |
| Registered establishments | BAYLIS MEDICAL TECHNOLOGIES INC. |
| Establishment registrations | 3020968442 |
| FEI numbers | 3020968442 |
| Establishment operations | Complaint File Establishment, Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 1–9 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