Medtronic Model 5392 External Pulse Generator (EPG)
FDA 510(k) K190825 · Medtronic, Inc.
510(k) numberK190825
Submission
- Device name
- Medtronic Model 5392 External Pulse Generator (EPG)
- Applicant
- Medtronic, Inc.
Mounds View, MN, US - Received
- April 1, 2019
- Decision date
- April 30, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DTE – Pulse-Generator, Pacemaker, External
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.3600
- Specialty
- Cardiovascular
Other 510(k)s with product code DTE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K241781 | Solo Pace ControlDTE · Traditional | Solo Pace, Inc. | 01/10/2025SE |
| K232721 | Lifetech Cardio Temporary PacemakerDTE · Special | Shenzhen Lifetech Cardio Medical Electronics… | 01/07/2024SE |
| K201011 | Medtronic Model 5392 External Pulse Generator (EPG)DTE · Special | Medtronic, Inc. | 05/13/2020SE |
| K182839 | Lifetech Cardio Model 8301 Temporary PacemakerDTE · Traditional | Shenzhen Lifetech Cardio Medical Electronics… | 02/28/2019SE |
| K181973 | Medtronic Model 5392 External Pulse Generator (EPG)DTE · Special | Medtronic, Inc. | 08/21/2018SE |
| K180873 | Medtronic Model 53401 External Pulse Generator (EPG)DTE · Special | Medtronic, Inc. | 04/19/2018SE |
| K162054 | Medtronic Temporary External Pacemaker 53401DTE · Traditional | Medtronic, Inc. | 10/18/2016SE |
| K162550 | Medtronic Model 5392 External Pulse Generator (EPG)DTE · Special | Medtronic, Inc. | 10/12/2016SE |
| K150246 | Medtronic Model 5392 External Pulse Generator (EPG)DTE · Special | Medtronic, Inc. | 02/18/2015SE |
| K132924 | Medtronic External Pulse Generator (Epg)DTE · Traditional | Medtronic, Inc. | 10/31/2013SE |
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Questions and answers
When was Medtronic Model 5392 External Pulse Generator (EPG) cleared by the FDA?
Medtronic Model 5392 External Pulse Generator (EPG) (K190825) received a 510(k) decision of Substantially Equivalent on April 30, 2019, 29 days after the submission was received.
What is the product code of K190825?
The FDA product code is DTE – Pulse-Generator, Pacemaker, External, a Class II (moderate risk) device regulated under 21 CFR 870.3600.