FDA device listing
ClotTriever Sheath,Large Bore Syringe, 60 cc,Large Bore Syringe, 60 cc, 3-pack
FDA device listing 1643258312 · STRYKER CORP.
Key facts
| Proprietary names | ClotTriever Sheath,Large Bore Syringe, 60 cc,Large Bore Syringe, 60 cc, 3-pack |
|---|---|
| Owner/operator | STRYKER CORP. |
| Owner/operator number | 1811755 |
| Premarket submissions | K233815 |
| Product codes | DYB, KRA, QEW |
| Device names | DYB - Introducer, Catheter, KRA - Catheter, Continuous Flush, QEW - Peripheral Mechanical Thrombectomy With Aspiration |
| Device class | Class II |
| Classification regulations (21 CFR) | 870.1210, 870.1340, 870.5150 |
| Review panels | Cardiovascular |
| Registered establishments | Inari Medical, Inc. |
| Establishment registrations | 3020347218 |
| FEI numbers | 3020347218 |
| Establishment operations | 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