FDA device listing
Arcadia High Pressure Inflation Syringe (IN55KVCF, IN55VCF),basixCOMPAK Inflation Device,basixSKY Inflation…
FDA device listing 1819488087 · Terumo BCT, INC.
Key facts
| Proprietary names | Arcadia High Pressure Inflation Syringe (IN55KVCF, IN55VCF),basixCOMPAK Inflation Device,basixSKY Inflation Device,basixTAU,basixTOUCH,basixTOUCH40 Inflation Syringe,BIG60 ALPHA Inflation Device |
|---|---|
| Owner/operator | Terumo BCT, INC. |
| Owner/operator number | 9002708 |
| Product codes | PTM |
| Device names | PTM - Syringe, Balloon Inflation, Exempt |
| Device class | Class II |
| Classification regulations (21 CFR) | 870.1650 |
| Review panels | Cardiovascular |
| Registered establishments | Terumo BCT STERILIZATION SERVICES, Inc. |
| Establishment registrations | 1724474 |
| FEI numbers | 3003094851 |
| Establishment operations | Contract Sterilizer |
| 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