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510(k) K252405

Medline ReNewal Reprocessed Boston Scientific Dynamic Tip Unidirectional Steerable Diagnostic Catheter by Surgical Instrument Service and Savings, Inc. — Product Code NLH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 26, 2025
Date Received
July 31, 2025
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 Surgical Instrument Service and Savings, Inc.

  • K250314 — Medline ReNewal Reprocessed Abbott Agilis Nxt Steerable Introducer (December 19, 2025)
  • K250772 — Medline ReNewal Reprocessed Boston Scientific Dynamic XT Unidirectional Steerabl (July 11, 2025)
  • K250545 — Medline ReNewal Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound (June 5, 2025)
  • K243101 — Medline ReNewal Reprocessed Siemens ACUSON AcuNav 10F Ultrasound Catheter (for S (March 10, 2025)
  • K242225 — Medline ReNewal Reprocessed Abbott Inquiry Steerable Diagnostic Catheter (November 29, 2024)
  • K241156 — Medline ReNewal Reprocessed St. Jude Medical Response Electrophysiology Catheter (September 14, 2024)
  • K234064 — Medline ReNewal Reprocessed Siemens ACUSON AcuNav 8F Ultrasound Catheter (for Si (September 10, 2024)
  • K240972 — Medline ReNewal Reprocessed Medtronic Achieve Catheter Connecting Cable (2ACHC) (June 7, 2024)
  • K232511 — Medline ReNewal Reprocessed LigaSure Exact Dissector, Nano-coated (LF2019) (April 29, 2024)
  • K221067 — Medline ReNewal Reprocessed St. Jude Medical Livewire Steerable Electrophysiolog (May 31, 2023)

Other clearances for product code NLH

  • 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)
  • K240972 — Medline ReNewal Reprocessed Medtronic Achieve Catheter Connecting Cable (2ACHC) (June 7, 2024)
  • K233825 — Reprocessed Webster Duo-Decapolar Diagnostic EP Catheter (June 7, 2024)
  • K221067 — Medline ReNewal Reprocessed St. Jude Medical Livewire Steerable Electrophysiolog (May 31, 2023)
  • K221854 — Reprocesses Umbilical Cable (August 6, 2022)
  • K211276 — Reprocessed Dynamic Tip and XT Steerable Diagnostic Electrophysiology Catheters (September 15, 2021)