FDA device listing
Liposorber LA-15 system
FDA device listing 1659740035 · Asahi Kasei Medical Co., Ltd.
Key facts
| Proprietary names | Liposorber LA-15 system |
|---|---|
| Owner/operator | Asahi Kasei Medical Co., Ltd. |
| Owner/operator number | 10040402 |
| Product codes | PBN |
| Device names | PBN - Apheresis For Focal Glomerulosclerosis In Adult And Pediatric Patients |
| Device class | HDE |
| Classification regulations (21 CFR) | ORCA1.PBN |
| Review panels | Gastroenterology & Urology |
| Registered establishments | Asahi Kasei Medical MT Corp. Oita Works |
| Establishment registrations | 8010002 |
| FEI numbers | 3002806407 |
| Establishment operations | Contract 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