FDA device listing

Kitazato IUI Catheter without Stainless Steel Center Core Type, 10 cm, model number Type 2-v1,Kitazato IUI Catheter…

FDA device listing 1184454280 · Kitazato Corporation

Key facts

Proprietary names Kitazato IUI Catheter without Stainless Steel Center Core Type, 10 cm, model number Type 2-v1,Kitazato IUI Catheter without Stainless Steel Center Core Type, 7 cm, model number Type 2-v2,Kitazato IUI Catheter with Stainless Steel Center Core Type, 10 cm, model number Type 1-v1,Kitazato IUI Catheter with Stainless Steel Center Core Type, 7 cm, model number Type 1-v2
Owner/operator Kitazato Corporation
Owner/operator number 10045321
Premarket submissions K112396
Product codes MQF
Device names MQF - Catheter, Assisted Reproduction
Device class Class II
Classification regulations (21 CFR) 884.6110
Review panels Obstetrics/Gynecology
Registered establishments KITAZATO CORPORATION
Establishment registrations 3008876063
FEI numbers 3008876063
Establishment operations Foreign Exporter, Manufacturer
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

Browse all FDA device listings