Home / 510(k) Clearances / K233943

510(k) K233943

Affera Mapping System (AFR-00003); Location Reference Patch Kit (AFR-00007); System Cart (AFR-00013) by Medtronic, Inc. — Product Code DQK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 8, 2024
Date Received
December 14, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Computer, Diagnostic, Programmable
Device Class
Class II
Regulation Number
870.1425
Review Panel
CV
Submission Type

Other clearances by Medtronic, Inc.

  • K253203 — Retrograde Coronary Sinus Perfusion Cannulae (February 19, 2026)
  • K253998 — Clearview Intracoronary Shunts (January 20, 2026)
  • K251744 — Affinity Pixie™ Arterial Filter with Balance™ Biosurface; Affinity® Pediatric Ar (January 16, 2026)
  • K251831 — Bio-Medicus Life Support Catheter and Introducer (January 15, 2026)
  • K253511 — Concerto Versa™ Detachable Coil (January 14, 2026)
  • K253409 — C320LBB Delivery System (C320LBBS45), C320LBB Delivery System (C320LBBS48), C320 (December 19, 2025)
  • K251258 — MC2™ Two-Stage Venous Cannula; MC2X™ Three-Stage Venous Cannula (June 20, 2025)
  • K250075 — Medtronic Stedi Extra Support Guidewire (June 13, 2025)
  • K250199 — VitalFlow Console (May 20, 2025)
  • K250558 — SelectSite C304 Deflectable Catheter System (C304); C315 Delivery System (C315) (March 27, 2025)

Other clearances for product code DQK

  • K253861 — ACORYS MAPPING SYSTEM (April 13, 2026)
  • K253473 — Synchrony (April 1, 2026)
  • K253186 — HemoSphere Nano Monitor (HSNANO1) (February 24, 2026)
  • K252972 — CARTO™ 3 EP Navigation System V8.4 (February 20, 2026)
  • K254089 — IOPS Visionary System (MC-3); IOPS Viewpoint Simple Curve Catheter, 75cm (C00751 (February 17, 2026)
  • K251591 — Holter ECG and ABP system (HolterABP) (February 9, 2026)
  • K251218 — SafeBeat Rx App (February 6, 2026)
  • K252164 — NorthStar™ Mapping System (January 28, 2026)
  • K254085 — CARTO™ 3 EP Navigation System V9.0 with PIU Plus (January 18, 2026)
  • K253733 — STAR Apollo™ Mapping System (December 19, 2025)