FDA device listing

Set, Administration, Intravascular

FDA device listing 1633714124 · Yangzhou Weideli Trading Co., Ltd.

Key facts

Owner/operator Yangzhou Weideli Trading Co., Ltd.
Owner/operator number 10034893
Premarket submissions K230992
Product codes FPA
Device names FPA - Set, Administration, Intravascular
Device class Class II
Classification regulations (21 CFR) 880.5440
Review panels General Hospital
Registered establishments YANGZHOU WEIDELI TRADING CO., LTD., Yangzhou Xingwei Medical Technology Co. , LTD
Establishment registrations 3008808123, 3044994889
FEI numbers 3008808123, 3044994889
Establishment operations Contract Manufacturer, 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

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