Temporary Pacemaker Extension Cable, Models 5235, 5235A, 5235V, Temporary Pacemaker Surgical Extension Cable, Models 528
FDA 510(k) K001180 · Pace Medical
510(k) numberK001180
Submission
- Device name
- Temporary Pacemaker Extension Cable, Models 5235, 5235A, 5235V, Temporary Pacemaker Surgical Extension Cable, Models 528
- Applicant
- Pace Medical
Waltham, MA, US - Received
- April 11, 2000
- Decision date
- June 27, 2000
- 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 |
|---|---|---|
| K011980 | Adapter, Pacing Analyzer/Universal Pacing Adapter, Models 4820 and 4825DTE · Traditional | 09/12/2001SE |
| K012392 | Disposable Surgical Extension Cable, Model 4255 and Model 4260DSA · Traditional | 09/04/2001SE |
| K002204 | Pacemaker Extension Cable Models 4265,4265A, 4265V, 5265, 5265A, 5265VDTE · Traditional | 10/18/2000SE |
| K002497 | Model 4810 Analyzer Output AdapterDTC · Traditional | 10/10/2000SE |
| K002496 | Model 4815 AdapterDTN · Traditional | 10/10/2000SE |
| K925143 | Model 4800 Accupace Pacing System AnalyerDTE · Traditional | 09/27/1994SE |
| K931662 | Lead Introducer Set, Various Models and SizesDYB · Traditional | 08/31/1993SE |
| K922899 | Model 4280 Surgical Extension CableDSA · Traditional | 12/23/1992SE |
| K913805 | Miniature Models 4562/4563/4572/4573 PacemakerDTE · Traditional | 11/19/1991SE |
| K913134 | Model 4220DXY · Traditional | 08/22/1991SE |
Questions and answers
When was Temporary Pacemaker Extension Cable, Models 5235, 5235A, 5235V, Temporary Pacemaker Surgical Extension Cable, Models 528 cleared by the FDA?
Temporary Pacemaker Extension Cable, Models 5235, 5235A, 5235V, Temporary Pacemaker Surgical Extension Cable, Models 528 (K001180) received a 510(k) decision of Substantially Equivalent on June 27, 2000, 77 days after the submission was received.
What is the product code of K001180?
The FDA product code is DTE – Pulse-Generator, Pacemaker, External, a Class II (moderate risk) device regulated under 21 CFR 870.3600.