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510(k) K203655

Reprocessed Webster CS Bi-Directional Diagnostic EP Catheter, Reprocessed Webster CS Bi-Directional Diagnostic EP Catheter (with Auto ID) by Innovative Health, LLC — Product Code NLH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 4, 2021
Date Received
December 15, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Recording, Electrode, Reprocessed
Device Class
Class II
Regulation Number
870.1220
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)
  • 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)
  • K212165 — Reprocessed Carto Vizigo Bi-Directional Guiding Sheath (March 10, 2022)
  • K212776 — Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled (December 20, 2021)

Other clearances for product code NLH

  • K252405 — Medline ReNewal Reprocessed Boston Scientific Dynamic Tip Unidirectional Steerab (November 26, 2025)
  • K250772 — Medline ReNewal Reprocessed Boston Scientific Dynamic XT Unidirectional Steerabl (July 11, 2025)
  • K242225 — Medline ReNewal Reprocessed Abbott Inquiry Steerable Diagnostic Catheter (November 29, 2024)
  • K241224 — Medline ReNewal Reprocessed Biosense Webster Webster CS Catheter with EZ Steer T (November 15, 2024)
  • K240826 — Reprocessed DECANAV™ Electrophysiology Catheter; Reprocessed WEBSTER® Duo-Decapo (October 11, 2024)
  • K241156 — Medline ReNewal Reprocessed St. Jude Medical Response Electrophysiology Catheter (September 14, 2024)
  • K233825 — Reprocessed Webster Duo-Decapolar Diagnostic EP Catheter (June 7, 2024)
  • K240972 — Medline ReNewal Reprocessed Medtronic Achieve Catheter Connecting Cable (2ACHC) (June 7, 2024)
  • K221067 — Medline ReNewal Reprocessed St. Jude Medical Livewire Steerable Electrophysiolog (May 31, 2023)
  • K221854 — Reprocesses Umbilical Cable (August 6, 2022)