FDA device listing
Atrion QL Inflation Device; Atrion QL Disposable Inflation Device; Atrion QL1030;,BD Eagle Inflation Device 10cc/30ATM…
FDA device listing 1128679600 · ATRION CORP.
Key facts
| Proprietary names | Atrion QL Inflation Device; Atrion QL Disposable Inflation Device; Atrion QL1030;,BD Eagle Inflation Device 10cc/30ATM REF 325110,BD Eagle Inflation Device 20cc/30ATM REF 325130,QL 1015 Inflation Device; QL 1020 Inflation Device,QL Inflation Device |
|---|---|
| Owner/operator | ATRION CORP. |
| Owner/operator number | 9914015 |
| Premarket submissions | K962611 |
| Product codes | KOE |
| Device names | KOE - Dilator, Urethral |
| Device class | Class II |
| Classification regulations (21 CFR) | 876.5520 |
| Review panels | Gastroenterology & Urology |
| Registered establishments | ATRION MEDICAL PRODUCTS, INC. |
| Establishment registrations | 1043729 |
| FEI numbers | 1043729 |
| Establishment operations | Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 1–9 UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes 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