Chronocor Vi Model 5012
FDA 510(k) K915364 · Seamed Corp.
510(k) numberK915364
Submission
- Device name
- Chronocor Vi Model 5012
- Applicant
- Seamed Corp.
Bothell, WA, US - Received
- November 27, 1991
- Decision date
- February 7, 1992
- 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 |
|---|---|---|
| K923398 | Cpi Model 2215DTE · Traditional | 08/14/1992SE |
| K912507 | Cpi Model 2215 & Seamed Model 3400DTE · Traditional | 09/03/1991SE |
| K910223 | Cpi Model 2215/SEAMED Model 3400DTC · Traditional | 03/19/1991SE |
| K883930 | Seamed Model 3300 Dual Chamber Pacing System AnalyDTE · Traditional | 11/09/1988SE |
| K872551 | Seamed Model 3200DTE · Traditional | 07/31/1987SE |
| K863903 | Sea Med Model 6000DTE · Traditional | 12/10/1986SE |
| K860462 | Seamed Model 3000DTC · Traditional | 08/19/1986SE |
| K854648 | Seamed Model 4000DTE · Traditional | 01/16/1986SE |
| K852746 | External Pacemaker Telectronics TE200JOQ · Traditional | 09/12/1985SE |
| K851900 | Sea Med DDD Pacing System AnalyzerDTC · Traditional | 07/19/1985SE |
Questions and answers
When was Chronocor Vi Model 5012 cleared by the FDA?
Chronocor Vi Model 5012 (K915364) received a 510(k) decision of Substantially Equivalent on February 7, 1992, 72 days after the submission was received.
What is the product code of K915364?
The FDA product code is DTE – Pulse-Generator, Pacemaker, External, a Class II (moderate risk) device regulated under 21 CFR 870.3600.