FDA device listing

Vascular Hook, Cardiovascular

FDA device listing 1132374716 · ASOL Co.,LTD

Key facts

Proprietary names Vascular Hook, Cardiovascular
Owner/operator ASOL Co.,LTD
Owner/operator number 10060679
Product codes DWS
Device names DWS - Instruments, Surgical, Cardiovascular
Device class Class I
Classification regulations (21 CFR) 870.4500
Review panels Cardiovascular
Registered establishments ASOL CO.,LTD
Establishment registrations 3013938829
FEI numbers 3013938829
Establishment operations Foreign Exporter, Manufacturer
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

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