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510(k) K201652

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

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

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  • K203540 — Bridge Occlusion Balloon (December 23, 2020)
  • K200459 — pREBOA-PRO Catheter (June 3, 2020)