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510(k) K243795

pREBOA-PRO Catheter by Prytime Medical Devices, Inc. — Product Code MJN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 5, 2025
Date Received
December 10, 2024
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 Prytime Medical Devices, Inc.

  • K200459 — pREBOA-PRO Catheter (June 3, 2020)
  • K193440 — ER-REBOA PLUS Catheter (January 9, 2020)
  • K172790 — ER-REBOA Catheter (November 8, 2017)
  • K170411 — ER-REBOA Catheter (April 4, 2017)

Other clearances for product code MJN

  • 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)
  • K200459 — pREBOA-PRO Catheter (June 3, 2020)