FDA device listing
Indigo® Aspiration System - Aspiration Catheter 12 and Separator 12
FDA device listing 1831384577 · PENUMBRA, INC.
Key facts
| Proprietary names | Indigo® Aspiration System - Aspiration Catheter 12 and Separator 12 |
|---|---|
| Owner/operator | PENUMBRA, INC. |
| Owner/operator number | 9072336 |
| Premarket submissions | K192981 |
| Product codes | QEW |
| Device names | QEW - Peripheral Mechanical Thrombectomy With Aspiration |
| Device class | Class II |
| Classification regulations (21 CFR) | 870.5150 |
| Review panels | Cardiovascular |
| Registered establishments | Penumbra Inc., PENUMBRA, INC. |
| Establishment registrations | 3005168196, 3013758550, 3015615738, 3016591327 |
| FEI numbers | 3005168196, 3013758550, 3015615738, 3016591327 |
| Establishment operations | 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