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510(k) K131869

PTS-X SIZING BALLOON CATHETER by NuMED, Inc. — Product Code MJN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 8, 2013
Date Received
June 24, 2013
Clearance Type
Special
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

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  • K171206 — D'Vill Introducer (October 20, 2017)
  • K161451 — BIB Stent Placement Catheter (September 22, 2016)
  • K160598 — REBOA Balloon Catheter (June 20, 2016)
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  • 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)