FDA device listing
ATS Cyclindrical Cuff, Single Port/Dual Bladder,ATS Cylindrical Cuff, Dual Port/Dual Bladder,ATS Cylindrical Cuff, Dual…
FDA device listing 1353598449 · ZIMMER, INC.
Key facts
| Proprietary names | ATS Cyclindrical Cuff, Single Port/Dual Bladder,ATS Cylindrical Cuff, Dual Port/Dual Bladder,ATS Cylindrical Cuff, Dual Port/Single Bladder,ATS Cylindrical Cuff, Single Port/Single Bladder,ATS Tourniquet Systems,Basket,Dual Port, Dual Bladder, cuff with PLC and protective sleeve,Dual Port/Dual Bladder Disposable Cuff,Dual Port/Single Bladder Contour Lge Thigh Cuff,Dual Port, Single Bladder cuff… |
|---|---|
| Owner/operator | ZIMMER, INC. |
| Owner/operator number | 1822565 |
| Product codes | KCY |
| Device names | KCY - Tourniquet, Pneumatic |
| Device class | Class I |
| Classification regulations (21 CFR) | 878.5910 |
| Review panels | General & Plastic Surgery |
| Registered establishments | ZIMMER, INC., ZIMMER SURGICAL, INC. |
| Establishment registrations | 1526350, 1822565 |
| FEI numbers | 1526350, 1000220733 |
| Establishment operations | Manufacturer, Repackager/Relabeler, Specification Developer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed 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