FDA device listing
Graftmaster,Graftmaster RX
FDA device listing 1518583456 · ABBOTT LABORATORIES
Key facts
| Proprietary names | Graftmaster,Graftmaster RX |
|---|---|
| Owner/operator | ABBOTT LABORATORIES |
| Owner/operator number | 1415939 |
| Premarket submissions | H000001 |
| Product codes | DYG, MAF, NIV |
| Device names | DYG - Catheter, Flow Directed, MAF - Stent, Coronary, NIV - Coronary Covered Stent |
| Device class | Class II, Class III, HDE |
| Classification regulations (21 CFR) | 870.1240, ORCA1.MAF, ORCA1.NIV |
| Review panels | Cardiovascular |
| Registered establishments | ABBOTT VASCULAR, Abbott Vascular Netherlands |
| Establishment registrations | 2024168, 2939561, 3004091615, 3005718570 |
| FEI numbers | 2024168, 3004091615, 3004635528, 3005718570 |
| Establishment operations | Complaint File Establishment, Foreign Exporter, Manufacturer, Specification Developer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 10–99 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