FDA device listing

Vasc Band

FDA device listing 1447678918 · Lepu Medical Technology (Beijing) Co., Ltd

Key facts

Proprietary names Vasc Band
Owner/operator Lepu Medical Technology (Beijing) Co., Ltd
Owner/operator number 10038811
Premarket submissions K142359
Product codes DXC
Device names DXC - Clamp, Vascular
Device class Class II
Classification regulations (21 CFR) 870.4450
Review panels Cardiovascular
Registered establishments Beijing Target Medical Technologies Inc., LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD
Establishment registrations 3008002401, 3011564431, 3018312328
FEI numbers 3008002401, 3011564431, 3018312328
Establishment operations Contract Sterilizer, Manufacturer
Registration valid through 2026

At a glance

  • 1–9 Registered establishments listing this device
  • 10–99 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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