Home / 510(k) Clearances / K231328

510(k) K231328

LUX-Dx II (M302); LUX-Dx II+ (M312) by Boston Scientific Corp — Product Code MXD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 19, 2023
Date Received
May 8, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)
Device Class
Class II
Regulation Number
870.1025
Review Panel
CV
Submission Type

Other clearances by Boston Scientific Corp

  • K252910 — Orca Air/Water and Suction Valves (October 9, 2025)
  • K251291 — Advanix™ Pancreatic Stent and NaviFlex™ Rapid Exchange (RX) Pancreatic Delivery (July 3, 2025)
  • K250468 — iSLEEVE Introducer Set (March 20, 2025)
  • K242950 — WallFlex Biliary PLUS RX Stent System (December 6, 2024)
  • K243245 — IceSeed 1.5 CX Straight Needle (H7493968333170); IceSphere1.5 CX Straight Needle (October 18, 2024)
  • K242507 — OBSIDIO™ Conformable Embolic (October 3, 2024)
  • K240464 — WallFlex Biliary RX Stent System; Epic Biliary Stent System; WallFlex Biliary RX (August 30, 2024)
  • K233939 — Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent System (April 29, 2024)
  • K234002 — ICEfx Cryoablation System (FPRCH8000-02) (March 13, 2024)
  • K232633 — Gold Probe Bipolar Electrohemostasis Catheter; Injection Gold Probe Bipolar Elec (November 28, 2023)

Other clearances for product code MXD

  • K253516 — Assert-IQ (DM5100) (December 18, 2025)
  • K251221 — Assert-IQ (DM5000); Assert-IQ (DM5300); Assert-IQ (DM5500); Merlin.net (MN7000) (September 17, 2025)
  • K252593 — LUX-Dx II Insertable Cardiac Monitor (M302); LUX-Dx II+ Insertable Cardiac Monit (September 12, 2025)
  • K240693 — LINQ II™ Insertable Cardiac Monitor (ICM) (March 28, 2024)
  • K233562 — LINQ II Insertable Cardiac Monitor (December 6, 2023)
  • K233320 — LINQ II™ Insertable Cardiac Monitor (LNQ22) (October 31, 2023)
  • K230375 — BIOMONITOR IV (May 19, 2023)
  • K230553 — LINQ II Insertable Cardiac Monitor, CareLink SmartSync LINQ II ICM Application (April 26, 2023)
  • K223630 — Reveal LINQ Insertable Cardiac Monitor, LINQ II Insertable Cardiac Monitor, Accu (April 5, 2023)
  • K221962 — LINQ II Insertable Cardiac Monitor (August 25, 2022)