Micropulse 26U Pulse Generator
FDA 510(k) K771987 · Edwards Pacemaker Systems
510(k) numberK771987
Submission
- Device name
- Micropulse 26U Pulse Generator
- Applicant
- Edwards Pacemaker Systems
Mchenry, IL, US - Received
- October 19, 1977
- Decision date
- November 2, 1977
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DXY – Implantable Pacemaker Pulse-Generator
- Device class
- Class III (high risk)
- Regulation
- 21 CFR 870.3610
- Specialty
- Cardiovascular
- Implant
- Yes
Other 510(k)s with product code DXY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K993434 | Pikos 01, Pikos E01, Pikos 01-B, Pikos E01-B, Pikos 01-A, Pikos E01-ADXY · Special | Biotronik, Inc. | 11/10/1999SE |
| K970072 | Opus S Model 4121 and 4124 PacemakersDXY · Traditional | Ela Medical, Inc. | 08/29/1997ST |
| K945627 | Pikos LP 01, Pikos LP E01DXY · Traditional | Biotronik, Inc. | 03/04/1996SESP |
| K954092 | Alternate Sterlization Process & Modified DF-1 Lead Connector (Modification)DXY · Traditional | Medtronic Vascular | 12/15/1995ST |
| K953866 | Minix 834M & Minix ST 8331M Pulse Generators (Modification)DXY · Traditional | Medtronic Vascular | 12/15/1995ST |
| K953417 | Miniflex Model 340, 341, and 342 Pulse GeneratorsDXY · Traditional | Cook Pacemaker Corp. | 09/29/1995ST |
| K952328 | Nanos, Pikos 01/E01, 01-A, E01-B, LP 01/LP E01DXY · Traditional | Biotronik, Inc. | 09/29/1995ST |
| K952364 | Opus Pacemakers (Models 4001, 4003, 4004, 4023, 4024)DXY · Traditional | Ela Medical, Inc. | 09/01/1995ST |
| K940039 | Pellethane 75DDXY · Traditional | Medtronic Vascular | 07/12/1995ST |
| K950751 | Tecothane 75D Polyurethane Resin for Pulse Generator Connector ModulesDXY · Traditional | Medtronic Vascular | 05/15/1995ST |
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 |
| K781144 | Analyzer, Pacer System, PSA-5DTC · Traditional | 08/23/1978SE |
| 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 |
| K770657 | Generator, Pulse, Cardiac 2LUDXY · Traditional | 04/26/1977SE |
| K770656 | Generator, Pulse, Cardiac 20UDXY · Traditional | 04/26/1977SE |
Questions and answers
When was Micropulse 26U Pulse Generator cleared by the FDA?
Micropulse 26U Pulse Generator (K771987) received a 510(k) decision of Substantially Equivalent on November 2, 1977, 14 days after the submission was received.
What is the product code of K771987?
The FDA product code is DXY – Implantable Pacemaker Pulse-Generator, a Class III (high risk) device regulated under 21 CFR 870.3610.