FDA device listing

Kelly-Wick AV Access Tunneler

FDA device listing 1706566204 · C. R. Bard, Inc.

Key facts

Proprietary names Kelly-Wick AV Access Tunneler
Owner/operator C. R. Bard, Inc.
Owner/operator number 2212754
Product codes DWS
Device names DWS - Instruments, Surgical, Cardiovascular
Device class Class I
Classification regulations (21 CFR) 870.4500
Review panels Cardiovascular
Registered establishments BARD PERIPHERAL VASCULAR, INC.
Establishment registrations 2020394
FEI numbers 2020394
Establishment operations Complaint File Establishment, 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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