Pulse Generator Model 629
FDA 510(k) K790670 · Elema-Schonander, Inc.
510(k) numberK790670
Submission
- Device name
- Pulse Generator Model 629
- Applicant
- Elema-Schonander, Inc.
Mchenry, IL, US - Received
- April 6, 1979
- Decision date
- June 27, 1979
- 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 |
|---|---|---|
| K934944 | MPQ-42IZP · Traditional | 12/15/1993SE |
| K904103 | Sep 90IZP · Traditional | 11/20/1990SE |
| K903576 | Puck 90MKPX · Traditional | 09/04/1990SE |
| K842911 | Puck U & Ud Cutfilm ChangersKPX · Traditional | 08/21/1984SE |
| K842903 | Sep Programmer for Puck U & Ud FilmchangIZP · Traditional | 08/21/1984SE |
| K840389 | Sep Programmer Sep-M/Single-Plane &IZP · Traditional | 02/21/1984SE |
| K790792 | Pulse Generator Model 637DXY · Traditional | 10/12/1979SE |
| K781178 | Pulse Generator Model 208DXY · Traditional | 09/07/1978SE |
| K770005 | Pacemaker 208SDXY · Traditional | 02/24/1977SE |
| K770135 | Lead ModificationDXY · Traditional | 02/07/1977SE |
Questions and answers
When was Pulse Generator Model 629 cleared by the FDA?
Pulse Generator Model 629 (K790670) received a 510(k) decision of Substantially Equivalent on June 27, 1979, 82 days after the submission was received.
What is the product code of K790670?
The FDA product code is DXY – Implantable Pacemaker Pulse-Generator, a Class III (high risk) device regulated under 21 CFR 870.3610.