Galix Pacestar
FDA 510(k) K023080 · Galix Biomedical Instrumentation, Inc.
510(k) numberK023080
Submission
- Device name
- Galix Pacestar
- Applicant
- Galix Biomedical Instrumentation, Inc.
Miami Beach, FL, US - Received
- September 17, 2002
- Decision date
- June 11, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
| K190825 | Medtronic Model 5392 External Pulse Generator (EPG)DTE · Special | Medtronic, Inc. | 04/30/2019SE |
| 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 |
More from Medtronic, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K092853 | 3 Channel Digital Ambulatory ECG Recorder Model Galix GBI-3SMMLO · Traditional | 07/09/2010SE |
| K051163 | Galix ECG Professional StationDPS · Traditional | 01/31/2006SE |
| K030145 | Galix WinterDQK · Traditional | 09/17/2003SE |
| K992706 | Galix Gbi -3S-LPMLO · Traditional | 03/15/2001SE |
| K971670 | 3 Channel Digital Ambulatory ECG RecorderDSH · Traditional | 01/29/1998SE |
Questions and answers
When was Galix Pacestar cleared by the FDA?
Galix Pacestar (K023080) received a 510(k) decision of Substantially Equivalent on June 11, 2003, 267 days after the submission was received.
What is the product code of K023080?
The FDA product code is DTE – Pulse-Generator, Pacemaker, External, a Class II (moderate risk) device regulated under 21 CFR 870.3600.