FDA device listing
Cooley Dilator,Cooley Vessel Dilator,Debakey Vascular Dilator,Garrett Vascular Dilator,Hiebert Vascular…
FDA device listing 1986270555 · Fetzer Medical GmbH & Co.KG
Key facts
| Proprietary names | Cooley Dilator,Cooley Vessel Dilator,Debakey Vascular Dilator,Garrett Vascular Dilator,Hiebert Vascular Dilator,Myocardial Dilator,Sarns Dilator |
|---|---|
| Owner/operator | Fetzer Medical GmbH & Co.KG |
| Owner/operator number | 10029400 |
| Product codes | DWP |
| Device names | DWP - Dilator, Vessel, Surgical |
| Device class | Class II |
| Classification regulations (21 CFR) | 870.4475 |
| Review panels | Cardiovascular |
| Registered establishments | FETZER MEDICAL GMBH & CO.KG |
| Establishment registrations | 3007648354 |
| FEI numbers | 3007648354 |
| 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