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510(k) K250314

Medline ReNewal Reprocessed Abbott Agilis Nxt Steerable Introducer by Surgical Instrument Service and Savings, Inc. — Product Code PNE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 19, 2025
Date Received
February 4, 2025
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 Surgical Instrument Service and Savings, Inc.

  • 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)
  • 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 PNE

  • K250305 — Reprocessed Agilis NxT Steerable Introducer (January 7, 2026)
  • K232037 — Reprocessed VersaCross Steerable Sheath; Reprocessed SureFlex Steerable Guiding (April 4, 2024)
  • K230376 — Reprocessed Agilis NxT Steerable Introducer (August 7, 2023)
  • K212165 — Reprocessed Carto Vizigo Bi-Directional Guiding Sheath (March 10, 2022)
  • K170311 — Reprocessed Agilis NxT Steerable Introducer (June 2, 2017)
  • K152090 — Reprocessed Steerable Introducer (March 23, 2016)