External Demand Pacemaker
FDA 510(k) K923621 · Oscor Medical Corp.
510(k) numberK923621
Submission
- Device name
- External Demand Pacemaker
- Applicant
- Oscor Medical Corp.
Palm Harbor, FL, US - Received
- July 21, 1992
- Decision date
- May 19, 1993
- 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 |
|---|---|---|
| K964107 | Oscor Permanent Retractable Screw-In Pacing Lead Model PRDTB · Traditional | 04/01/1997PT |
| K925168 | Miscellaneous Pacing LeadDTD · Traditional | 05/03/1994SE |
| K912867 | Oscor Medical Corp Permanent Pacing LeadDTB · Traditional | 02/04/1992SE |
| K915008 | Permanent Pacing Pad, ModificationDTB · Traditional | 01/27/1992SE |
| K915007 | Permanent Pacing Leads, ModificationDTB · Traditional | 01/27/1992SE |
| K913393 | Implant Pacing Lead, Retractable, ModificationDTB · Traditional | 09/23/1991SE |
| K913205 | Oscor Medical Fix Screw Pac Lead/Peel Cath, ModifDTB · Traditional | 09/23/1991SE |
| K913204 | Model Ky Pacemaker Lead-Various, ModificationDTB · Traditional | 09/23/1991SE |
| K913203 | Implant Pacing Lead Tined #3390, ModificationDTB · Traditional | 09/23/1991SE |
| K913202 | Implant Pacing Lead, Tined #3262, ModificationDTB · Traditional | 09/23/1991SE |
Questions and answers
When was External Demand Pacemaker cleared by the FDA?
External Demand Pacemaker (K923621) received a 510(k) decision of Substantially Equivalent on May 19, 1993, 302 days after the submission was received.
What is the product code of K923621?
The FDA product code is DTE – Pulse-Generator, Pacemaker, External, a Class II (moderate risk) device regulated under 21 CFR 870.3600.