Analyzer, Pacer System, PSA-5
FDA 510(k) K781144 · Edwards Pacemaker Systems
510(k) numberK781144
Submission
- Device name
- Analyzer, Pacer System, PSA-5
- Applicant
- Edwards Pacemaker Systems
Mchenry, IL, US - Received
- July 10, 1978
- Decision date
- August 23, 1978
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DTC – Analyzer, Pacemaker Generator Function
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.3630
- Specialty
- Cardiovascular
Other 510(k)s with product code DTC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K170815 | PSA CableDTC · Traditional | Boston Scientific Corporation | 07/06/2017SE |
| K083674 | PK-141 Patient CableDTC · Traditional | Biotronik, Inc. | 04/01/2009SE |
| K011729 | Sigma Pace External Pacemaker Analyzer Model #1000DTC · Traditional | Dni Nevada, Inc. | 08/30/2001SE |
| K002497 | Model 4810 Analyzer Output AdapterDTC · Traditional | Pace Medical | 10/10/2000SE |
| K961582 | External Pacemaker Analyzer, Model PMT 100DTC · Traditional | North American Technical Services Corp. | 11/08/1996SE |
| K903966 | External Pacemaker Analyzer Model PMA-1DTC · Traditional | Bio-Tek Instruments, Inc. | 06/19/1991SE |
| K910595 | Model 5311B A-V Pacing System AnalyzerDTC · Traditional | Medtronic Vascular | 05/07/1991SE |
| K910223 | Cpi Model 2215/SEAMED Model 3400DTC · Traditional | Seamed Corp. | 03/19/1991SE |
| K901332 | PK-55 Andover Medical Part #5455 Label ChangeDTC · Traditional | Biotronik, GmbH & Co. | 05/09/1990SE |
| K896632 | Medtronic Model 5401B Test CableDTC · Traditional | Medtronic Vascular | 12/13/1989SE |
More from Medtronic Vascular
| 510(k) | Device | Decision |
|---|---|---|
| K791751 | Edwards Pacemaker 30 Unipolar GeneratorDXY · Traditional | 09/26/1979SE |
| K790452 | 28 Unipolar and Bipolar Pulse GeneratorsDXY · Traditional | 05/08/1979SE |
| K781111 | Lead Conversion Kit, Model 341 · Traditional | 08/31/1978SE |
| K781042 | Prolith 23S PacemakerDXY · Traditional | 07/27/1978SE |
| K780780 | Micropulse 22S PacemakerDXY · Traditional | 06/30/1978SE |
| K780238 | Pacemaker, Prolith 23U. Pulse GeneratorDXY · Traditional | 03/15/1978SE |
| K780091 | Micropulse 22UDXY · Traditional | 01/30/1978SE |
| K771987 | Micropulse 26U Pulse GeneratorDXY · Traditional | 11/02/1977SE |
| K770657 | Generator, Pulse, Cardiac 2LUDXY · Traditional | 04/26/1977SE |
| K770656 | Generator, Pulse, Cardiac 20UDXY · Traditional | 04/26/1977SE |
Questions and answers
When was Analyzer, Pacer System, PSA-5 cleared by the FDA?
Analyzer, Pacer System, PSA-5 (K781144) received a 510(k) decision of Substantially Equivalent on August 23, 1978, 44 days after the submission was received.
What is the product code of K781144?
The FDA product code is DTC – Analyzer, Pacemaker Generator Function, a Class II (moderate risk) device regulated under 21 CFR 870.3630.