FDA device listing
Surfacer Inside-Out Access Catheter System
FDA device listing 1532989598 · Merit Medical Systems, Inc.
Key facts
| Proprietary names | Surfacer Inside-Out Access Catheter System |
|---|---|
| Owner/operator | Merit Medical Systems, Inc. |
| Owner/operator number | 1721504 |
| Premarket submissions | DEN190038 |
| Product codes | QJH |
| Device names | QJH - Reverse Central Venous Recanalization System |
| Device class | Class II |
| Classification regulations (21 CFR) | 870.1342 |
| Review panels | Cardiovascular |
| Registered establishments | Merit Maquiladora Mexico, S. DE R.L. DE C.V., Merit Medical Asia Company Limited, Merit Medical Australia Pty Ltd., Merit Medical Canada Ltd., Merit Medical Nederland BV, MERIT MEDICAL SYSTEMS, INC., Merit Medical UK Limited |
| Establishment registrations | 1721504, 3006950086, 3011642792, 3012536737, 3015225571, 3015309643, 3033589330 |
| FEI numbers | 1721504, 3006950086, 3011642792, 3012536737, 3015225571, 3015309643, 3033589330 |
| Establishment operations | Contract Manufacturer, Foreign Exporter, Specification Developer |
| 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