Neos-M VS-1 Pulse Generator
FDA 510(k) K863879 · Biotronik Sales, Inc.
510(k) numberK863879
Submission
- Device name
- Neos-M VS-1 Pulse Generator
- Applicant
- Biotronik Sales, Inc.
Lake Oswego, OR, US - Received
- October 6, 1986
- Decision date
- December 10, 1986
- 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 |
|---|---|---|
| K875199 | NP Bipolar Endocardial Lead W/VS-1 ConnectorDTB · Traditional | 02/18/1988SE |
| K853194 | ERA-20DTE · Traditional | 03/11/1987SE |
| K860036 | EDP-20 PacemakerDXY · Traditional | 01/12/1987SE |
| K863878 | Trios-M VS-1 Pulse GeneratorDXY · Traditional | 12/10/1986SE |
| K863480 | Biotronik Permanent Pacemaker ElectrodeDTB · Traditional | 09/23/1986SE |
| K860921 | Neos VS-1, Pulse GeneratorDXY · Traditional | 08/08/1986SE |
| K860922 | Mikros, Mikros VS-1, Pulse GeneratorDXY · Traditional | 08/04/1986SE |
| K853567 | DJP UnipolarDTB · Traditional | 05/07/1986SE |
| K853566 | DJ UnipolarDTB · Traditional | 05/07/1986SE |
| K853568 | DNR UnipolarDTB · Traditional | 01/15/1986SE |
Questions and answers
When was Neos-M VS-1 Pulse Generator cleared by the FDA?
Neos-M VS-1 Pulse Generator (K863879) received a 510(k) decision of Substantially Equivalent on December 10, 1986, 65 days after the submission was received.
What is the product code of K863879?
The FDA product code is DXY – Implantable Pacemaker Pulse-Generator, a Class III (high risk) device regulated under 21 CFR 870.3610.