Home / 510(k) Clearances / K210006

510(k) K210006

MI DeTACH by Biorep Technologies, Inc. — Product Code DXC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 4, 2021
Date Received
January 4, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Clamp, Vascular
Device Class
Class II
Regulation Number
870.4450
Review Panel
CV
Submission Type

Other clearances for product code DXC

  • K243627 — Laryngoscope Junctional-Arterial Restriction Clamp (L-ARC); Arterial Restriction (December 31, 2025)
  • K253070 — Namic Radial Arm Band, 23 cm (DYNJRADBAND); Namic Radial Arm Band, 26 cm (DYNJRA (November 20, 2025)
  • K232577 — Radial Compression Device (January 18, 2024)
  • K230281 — PICOCLAMP (October 23, 2023)
  • K221661 — Abdominal Aortic and Junctional Tourniquet - Stabilized (AAJT-S) (March 3, 2023)
  • K230248 — VIOLA (February 28, 2023)
  • K222182 — Radial Artery Compression Tourniquets (January 4, 2023)
  • K221843 — GEM Biover Microvascular Clamps (September 14, 2022)
  • K213531 — TR BAND Radial Compression Device (December 20, 2021)
  • K210681 — SiteSeal SV (April 6, 2021)