FDA device listing

LimFlow Vector

FDA device listing 1364420245 · STRYKER CORP.

Key facts

Proprietary names LimFlow Vector
Owner/operator STRYKER CORP.
Owner/operator number 1811755
Premarket submissions K260188
Product codes MGZ
Device names MGZ - Valvulotome
Device class Class II
Classification regulations (21 CFR) 870.4885
Review panels Cardiovascular
Registered establishments LimFlow Inc.
Establishment registrations 3023527320
FEI numbers 3023527320
Establishment operations 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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