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510(k) K201652

COBRA-OS Kit by Front Line Medical Technologies, Inc. — Product Code MJN

K201652 is an FDA 510(k) premarket notification submitted by Front Line Medical Technologies, Inc. for the device "COBRA-OS Kit". The FDA issued a decision of Substantially Equivalent (kit) on February 22, 2021. The device falls under product code MJN (Catheter, Intravascular Occluding, Temporary), a Class II device regulated under 21 CFR 870.4450.

Clearance Details

Decision
SESK (Substantially Equivalent (kit))
Decision Date
February 22, 2021
Date Received
June 18, 2020
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 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)
  • K203540 — Bridge Occlusion Balloon (December 23, 2020)
  • K200459 — pREBOA-PRO Catheter (June 3, 2020)

FDA data resources