Home / 510(k) Clearances / K160598

510(k) K160598

REBOA Balloon Catheter by NuMED, Inc. — Product Code MJN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 20, 2016
Date Received
March 2, 2016
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 NuMED, Inc.

  • K213915 — BIB Stent Placement Catheter (January 12, 2022)
  • K211910 — Z-6 Atrioseptostomy Catheter (July 19, 2021)
  • K211134 — BIB Stent Placement Catheter (May 27, 2021)
  • K190974 — D'Vill Introducer (May 14, 2019)
  • K171206 — D'Vill Introducer (October 20, 2017)
  • K161451 — BIB Stent Placement Catheter (September 22, 2016)
  • K160889 — BIB Stent Placement Catheter (May 20, 2016)
  • K131869 — PTS-X SIZING BALLOON CATHETER (August 8, 2013)
  • K122012 — Z-MED Z-MED II (October 4, 2012)
  • K121859 — TYSHAK NUCLEUS (August 31, 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)