FDA device listing
Disposable Platform Blades,FASTRACT Sternal Retractor,FASTRACT Suture Stay - Pair,FASTRACT Suture Stay - Single,OPHIDIA…
FDA device listing 1192161876 · KDL MEDICAL, INC. dba CHASE MEDICAL
Key facts
| Proprietary names | Disposable Platform Blades,FASTRACT Sternal Retractor,FASTRACT Suture Stay - Pair,FASTRACT Suture Stay - Single,OPHIDIA Vacuum Heart Stabilizer,TRIPOD Heart Stabilizer Lt Metal FASTRACT,TRIPOD Heart Stabilizer Lt Metal w/Occluder,TRIPOD Heart Stabilizer Lt Mtl FASTRACT +2cm,TRIPOD Heart Stabilizer Med Metal FASTRACT,TRIPOD Heart Stabilizer Nylon FASTRACT,TRIPOD Heart Stabilizer Nylon FASTRACT… |
|---|---|
| Owner/operator | KDL MEDICAL, INC. dba CHASE MEDICAL |
| Owner/operator number | 9028011 |
| Product codes | DWS |
| Device names | DWS - Instruments, Surgical, Cardiovascular |
| Device class | Class I |
| Classification regulations (21 CFR) | 870.4500 |
| Review panels | Cardiovascular |
| Registered establishments | KDL MEDICAL, INC. |
| Establishment registrations | 1649139 |
| FEI numbers | 3002406063 |
| Establishment operations | Complaint File Establishment, Manufacturer |
| 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