FDA device listing

EMBOTRAP III Revascularization Device

FDA device listing 1887641107 · Cerenovus, Inc.

Key facts

Proprietary names EMBOTRAP III Revascularization Device
Owner/operator Cerenovus, Inc.
Owner/operator number 9026915
Premarket submissions K211338
Product codes NRY
Device names NRY - Catheter, Thrombus Retriever
Device class Class II
Classification regulations (21 CFR) 870.1250
Review panels Cardiovascular
Registered establishments Cerenovus, Inc.
Establishment registrations 3008264254
FEI numbers 3008264254
Establishment operations Complaint File Establishment
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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