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510(k) K203540

Bridge Occlusion Balloon by Spectranetics, Inc. — Product Code MJN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 23, 2020
Date Received
December 3, 2020
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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Other clearances for product code MJN

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