FDA device listing
Arrow Thoracentesis Kit; Arrow-Clarke Pleura-Seal Thoracentesis Kit; Arrow-Clarke™ Pleura-Seal® Thoracentesis…
FDA device listing 1173067033 · Arrow International LLC (subsidiary of Teleflex Incorporated
Key facts
| Proprietary names | Arrow Thoracentesis Kit; Arrow-Clarke Pleura-Seal Thoracentesis Kit; Arrow-Clarke™ Pleura-Seal® Thoracentesis Set,Percutaneous Cavity DRAI; Percutaneous Cavity Drainage Catheterization Set/Kit,Pneumothorax Set |
|---|---|
| Owner/operator | Arrow International LLC (subsidiary of Teleflex Incorporated |
| Owner/operator number | 2518433 |
| Product codes | PAD |
| Device names | PAD - Chest Drainage Kit |
| Device class | Class II |
| Classification regulations (21 CFR) | 880.6740 |
| Review panels | General Hospital |
| Registered establishments | Arrow Internacional de Chihuahua S.A. de C.V., Arrow International CR, a.s., Arrow International, LLC (subsidiary of Teleflex Incorporated) |
| Establishment registrations | 9680794, 1000563940, 3015859709 |
| FEI numbers | 1000563940, 3003737899, 3015859709 |
| Establishment operations | Manufacturer, Repackager/Relabeler, Specification Developer |
| 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