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510(k) K110903

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 29, 2011
Date Received
March 31, 2011
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

Other clearances by NuMED, Inc.

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  • 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)
  • K160598 — REBOA Balloon Catheter (June 20, 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)

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)