FDA device listing

Teleflex (EP2) - Arrow Radial Artery,Teleflex (EP2) - Arterial Catheter,Teleflex (EP2) - Single Lumen CVC

FDA device listing 1428177036 · STERIS Corporation

Key facts

Proprietary names Teleflex (EP2) - Arrow Radial Artery,Teleflex (EP2) - Arterial Catheter,Teleflex (EP2) - Single Lumen CVC
Owner/operator STERIS Corporation
Owner/operator number 1527821
Product codes DQX
Device names DQX - Wire, Guide, Catheter
Device class Class II
Classification regulations (21 CFR) 870.1330
Review panels Cardiovascular
Registered establishments Isomedix Operations Inc
Establishment registrations 3009888344
FEI numbers 3009888344
Establishment operations Contract Sterilizer
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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