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510(k) K192998

Reprocessed BRK Transseptal Needle by Innovative Health, LLC — Product Code NMK

K192998 is an FDA 510(k) premarket notification submitted by Innovative Health, LLC for the device "Reprocessed BRK Transseptal Needle". The FDA issued a decision of Substantially Equivalent on July 22, 2020. The device falls under product code NMK (Trocar, Reprocessed), a Class II device regulated under 21 CFR 870.1390. Innovative Health, LLC has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 22, 2020
Date Received
October 28, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Trocar, Reprocessed
Device Class
Class II
Regulation Number
870.1390
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)

FDA data resources