Home / 510(k) Clearances / K162054

510(k) K162054

Medtronic Temporary External Pacemaker 53401 by Medtronic, Inc. — Product Code DTE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 18, 2016
Date Received
July 25, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pulse-Generator, Pacemaker, External
Device Class
Class II
Regulation Number
870.3600
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 DTE

  • K241781 — Solo Pace Control (January 10, 2025)
  • K232721 — Lifetech Cardio Temporary Pacemaker (January 7, 2024)
  • K201011 — Medtronic Model 5392 External Pulse Generator (EPG) (May 13, 2020)
  • K190825 — Medtronic Model 5392 External Pulse Generator (EPG) (April 30, 2019)
  • K182839 — Lifetech Cardio Model 8301 Temporary Pacemaker (February 28, 2019)
  • K181973 — Medtronic Model 5392 External Pulse Generator (EPG) (August 21, 2018)
  • K180873 — Medtronic Model 53401 External Pulse Generator (EPG) (April 19, 2018)
  • K162550 — Medtronic Model 5392 External Pulse Generator (EPG) (October 12, 2016)
  • K150246 — Medtronic Model 5392 External Pulse Generator (EPG) (February 18, 2015)
  • K132924 — MEDTRONIC EXTERNAL PULSE GENERATOR (EPG) (October 31, 2013)