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510(k) K232721

Lifetech Cardio Temporary Pacemaker by Shenzhen Lifetech Cardio Medical Electronics Co., Ltd. — Product Code DTE

K232721 is an FDA 510(k) premarket notification submitted by Shenzhen Lifetech Cardio Medical Electronics Co., Ltd. for the device "Lifetech Cardio Temporary Pacemaker". The FDA issued a decision of Substantially Equivalent on January 7, 2024. The device falls under product code DTE (Pulse-Generator, Pacemaker, External), a Class II device regulated under 21 CFR 870.3600. Shenzhen Lifetech Cardio Medical Electronics Co., Ltd. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 7, 2024
Date Received
September 5, 2023
Clearance Type
Special
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 Shenzhen Lifetech Cardio Medical Electronics Co., Ltd.

  • K182839 — Lifetech Cardio Model 8301 Temporary Pacemaker (February 28, 2019)

Other clearances for product code DTE

  • K241781 — Solo Pace Control (January 10, 2025)
  • 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)
  • K162054 — Medtronic Temporary External Pacemaker 53401 (October 18, 2016)
  • 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)

FDA data resources