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510(k) K212165

Reprocessed Carto Vizigo Bi-Directional Guiding Sheath by Innovative Health, LLC — Product Code PNE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 10, 2022
Date Received
July 12, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Reprocessed Catheter Introducer
Device Class
Class II
Regulation Number
870.1340
Review Panel
CV
Submission Type

Introduce various cardiovascular catheters into the heart and cardiovascular system

Other clearances by Innovative Health, LLC

  • K250305 — Reprocessed Agilis NxT Steerable Introducer (January 7, 2026)
  • K231015 — Reprocessed Super Torque and Super Torque Plus Diagnostic Angiographic Catheters (July 1, 2024)
  • K233825 — Reprocessed Webster Duo-Decapolar Diagnostic EP Catheter (June 7, 2024)
  • K232037 — Reprocessed VersaCross Steerable Sheath; Reprocessed SureFlex Steerable Guiding (April 4, 2024)
  • K230376 — Reprocessed Agilis NxT Steerable Introducer (August 7, 2023)
  • K213584 — Reprocessed NRG Transseptal Needle (April 4, 2023)
  • K221854 — Reprocesses Umbilical Cable (August 6, 2022)
  • K210655 — Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter (May 25, 2022)
  • K212776 — Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled (December 20, 2021)
  • K211662 — Reprocessed IntellaMap Orion High Resolution Mapping Catheter (November 18, 2021)

Other clearances for product code PNE

  • K250305 — Reprocessed Agilis NxT Steerable Introducer (January 7, 2026)
  • K250314 — Medline ReNewal Reprocessed Abbott Agilis Nxt Steerable Introducer (December 19, 2025)
  • K232037 — Reprocessed VersaCross Steerable Sheath; Reprocessed SureFlex Steerable Guiding (April 4, 2024)
  • K230376 — Reprocessed Agilis NxT Steerable Introducer (August 7, 2023)
  • K170311 — Reprocessed Agilis NxT Steerable Introducer (June 2, 2017)
  • K152090 — Reprocessed Steerable Introducer (March 23, 2016)