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510(k) K153530

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 5, 2016
Date Received
December 9, 2015
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

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  • K212784 — TightRail Guardian Motorized Dilator Sheath (August 24, 2022)
  • DEN210024 — CavaClear Laser Sheath (December 21, 2021)
  • K203540 — Bridge Occlusion Balloon (December 23, 2020)
  • K180694 — Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Ather (April 5, 2018)
  • K172687 — Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Ather (November 27, 2017)
  • K170059 — Spectranetics Turbo-Elite Laser Atherectomy Catheters (April 7, 2017)
  • K162561 — Turbo-Power (2.0mm) Laser Atherectomy Catheters (January 5, 2017)

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)