FDA device listing

Intravascular catheter securement

FDA device listing 1032664370 · Arrow International LLC (subsidiary of Teleflex Incorporated

Key facts

Proprietary names Intravascular catheter securement
Owner/operator Arrow International LLC (subsidiary of Teleflex Incorporated
Owner/operator number 2518433
Product codes KMK
Device names KMK - Device, Intravascular Catheter Securement
Device class Class I
Classification regulations (21 CFR) 880.5210
Review panels General Hospital
Registered establishments Arrow Internacional de Chihuahua S.A. de C.V., Arrow International C.R. a.s., Arrow International CR, a.s., Arrow International, LLC (subsidiary of Teleflex Incorporated)
Establishment registrations 9680794, 1000563940, 3006425876, 3015859709
FEI numbers 1000563940, 3003737899, 3006425876, 3015859709
Establishment operations Contract Manufacturer, Foreign Exporter, Repackager/Relabeler, Specification Developer
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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