FDA device listing

Tryton Side Branch Stent

FDA device listing 1597439185 · Poseidon Medical Inc.

Key facts

Proprietary names Tryton Side Branch Stent
Owner/operator Poseidon Medical Inc.
Owner/operator number 10062215
Premarket submissions P150039
Product codes MAF
Device names MAF - Stent, Coronary
Device class Class III
Classification regulations (21 CFR) ORCA1.MAF
Review panels Cardiovascular
Registered establishments POSEIDON MEDICAL INC.
Establishment registrations 3016248656
FEI numbers 3016248656
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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