Home / 510(k) Clearances / K231015

510(k) K231015

Reprocessed Super Torque and Super Torque Plus Diagnostic Angiographic Catheters by Innovative Health, LLC — Product Code NLI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 1, 2024
Date Received
April 10, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Angiography, Reprocessed
Device Class
Class II
Regulation Number
870.1200
Review Panel
CV
Submission Type

Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).

Other clearances by Innovative Health, LLC

  • K250305 — Reprocessed Agilis NxT Steerable Introducer (January 7, 2026)
  • 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)
  • K212165 — Reprocessed Carto Vizigo Bi-Directional Guiding Sheath (March 10, 2022)
  • K212776 — Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled (December 20, 2021)
  • K211662 — Reprocessed IntellaMap Orion High Resolution Mapping Catheter (November 18, 2021)