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510(k) K233917

ICHOR 7F Embolectomy System (ICH-7F) by Ichor — Product Code QEW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 18, 2024
Date Received
December 12, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Peripheral Mechanical Thrombectomy With Aspiration
Device Class
Class II
Regulation Number
870.5150
Review Panel
CV
Submission Type

To mechanically disrupt thrombus and/or debris prior to removal from the peripheral vasculature through aspiration.

Other clearances by Ichor

  • K230743 — ICHOR 14F Embolectomy System (September 5, 2023)

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