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510(k) K183679

Occlusion Balloon Catheter by Qxmedical, LLC — Product Code MJN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 24, 2019
Date Received
December 28, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Intravascular Occluding, Temporary
Device Class
Class II
Regulation Number
870.4450
Review Panel
CV
Submission Type

Other clearances by Qxmedical, LLC

  • K200317 — Support Catheter (May 14, 2020)
  • K160561 — Boosting Catheter (November 2, 2016)
  • K123311 — QXMEDICAL ACCESS & SUPPORT CATHETER (January 14, 2013)
  • K120381 — Q50 PLUS STENT GRAFT BALLOON CATHETER (February 24, 2012)

Other clearances for product code MJN

  • K243795 — pREBOA-PRO Catheter (September 5, 2025)
  • K251358 — Bridge Plus Occlusion Balloon (590-002) (June 24, 2025)
  • K221294 — preCARDIA Occlusion System (June 30, 2023)
  • K214060 — LANDMARK REBOA Catheter (September 19, 2022)
  • K211610 — Fogarty Occlusion Catheter (February 14, 2022)
  • K212324 — RenovoCath (August 23, 2021)
  • K210602 — AortaSTAT Occlusion Device (July 9, 2021)
  • K210358 — Neurescue device (May 21, 2021)
  • K201652 — COBRA-OS Kit (February 22, 2021)
  • K203540 — Bridge Occlusion Balloon (December 23, 2020)