DTE — Pulse-Generator, Pacemaker, External Class II

FDA Device Classification

Classification Details

Product Code
DTE
Device Class
Class II
Regulation Number
870.3600
Submission Type
Review Panel
CV
Medical Specialty
Cardiovascular
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K241781solo paceSolo Pace ControlJanuary 10, 2025
K232721shenzhen lifetech cardio medical electronics coLifetech Cardio Temporary PacemakerJanuary 7, 2024
K201011medtronicMedtronic Model 5392 External Pulse Generator (EPG)May 13, 2020
K190825medtronicMedtronic Model 5392 External Pulse Generator (EPG)April 30, 2019
K182839shenzhen lifetech cardio medical electronics coLifetech Cardio Model 8301 Temporary PacemakerFebruary 28, 2019
K181973medtronicMedtronic Model 5392 External Pulse Generator (EPG)August 21, 2018
K180873medtronicMedtronic Model 53401 External Pulse Generator (EPG)April 19, 2018
K162054medtronicMedtronic Temporary External Pacemaker 53401October 18, 2016
K162550medtronicMedtronic Model 5392 External Pulse Generator (EPG)October 12, 2016
K150246medtronicMedtronic Model 5392 External Pulse Generator (EPG)February 18, 2015
K132924medtronicMEDTRONIC EXTERNAL PULSE GENERATOR (EPG)October 31, 2013
K123916osypka medicalPSA SERIESApril 9, 2013
K042708biotronikERA 3000 PACING SYSTEM ANALYZEROctober 20, 2004
K033130osypka medicalPACE 101/PACE 101H, MODEL 3077 SSI TEMPORARY PULSE GENERATOROctober 31, 2003
K023080galix biomedical instrumentationGALIX PACESTARJune 11, 2003
K022939osypka medicalOSCOR PACE 101/101H AND ACCESSORIES, ST.JUDE MEDICAL MODEL 3077 AND ACCESSORIES,October 3, 2002
K020896osypka medicalOSCOR PACE 203/PACE 203H DUAL-CHAMBER TEMPORARY PACEMAKER, ST. JUDE MEDICAL, MODJune 14, 2002
K011980pace medicalADAPTER, PACING ANALYZER/UNIVERSAL PACING ADAPTER, MODELS 4820 AND 4825September 12, 2001
K002204pace medicalPACEMAKER EXTENSION CABLE MODELS 4265,4265A, 4265V, 5265, 5265A, 5265VOctober 18, 2000
K001180pace medicalTEMPORARY PACEMAKER EXTENSION CABLE, MODELS 5235, 5235A, 5235V, TEMPORARY PACEMAJune 27, 2000