FDA device listing
Angio-Seal,Angio-Seal VIP Vascular Closure Device
FDA device listing 1532508410 · TERUMO MEDICAL CORP.
Key facts
| Proprietary names | Angio-Seal,Angio-Seal VIP Vascular Closure Device |
|---|---|
| Owner/operator | TERUMO MEDICAL CORP. |
| Owner/operator number | 9003933 |
| Premarket submissions | P930038 |
| Product codes | MGB |
| Device names | MGB - Device, Hemostasis, Vascular |
| Device class | Class III |
| Classification regulations (21 CFR) | ORCA1.MGB |
| Review panels | Cardiovascular |
| Registered establishments | Terumo Medical Canada, Inc., TERUMO MEDICAL CORP., Terumo Puerto Rico LLC |
| Establishment registrations | 1118880, 2243441, 3008307705, 3013394970 |
| FEI numbers | 1118880, 2243441, 3008307705, 3013394970 |
| Establishment operations | Complaint File Establishment, Contract Sterilizer, Contract Manufacturer, Foreign Exporter, Specification Developer |
| 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