FDA device listing
Flexible Extension Handle (Replacement) (Tailor and Seguin sizer sets),Flexible Holder Handle (Biocor, Biocor Supra…
FDA device listing 1651992151 · ABBOTT LABORATORIES
Key facts
| Proprietary names | Flexible Extension Handle (Replacement) (Tailor and Seguin sizer sets),Flexible Holder Handle (Biocor, Biocor Supra, Epic, Epic Supra, Trifecta valve holder handle),Holder Handle (Biocor B30 series valve holder handle),Holder Handle (Biocor, Biocor Supra, Epic, Epic Supra valve holder handle),Holder Handle (Epic Plus and Epic Max),Masters HP Series Mechanical Heart Valve Replacement… |
|---|---|
| Owner/operator | ABBOTT LABORATORIES |
| Owner/operator number | 1415939 |
| Product codes | DTJ |
| Device names | DTJ - Holder, Heart-Valve, Prosthesis |
| Device class | Class I |
| Classification regulations (21 CFR) | 870.3935 |
| Review panels | Cardiovascular |
| Registered establishments | Abbott Medical |
| Establishment registrations | 2135147, 3007113487 |
| FEI numbers | 3005334138, 3007113487 |
| 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