Unifocal 3-2 Models Unipolar & Bipolar
FDA 510(k) K792232 · American Pacemaker Corp.
510(k) numberK792232
Submission
- Device name
- Unifocal 3-2 Models Unipolar & Bipolar
- Applicant
- American Pacemaker Corp.
Mchenry, IL, US - Received
- November 5, 1979
- Decision date
- November 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 |
|---|---|---|
| K821791 | External Pulse Generator - EV4542DTE · Traditional | 07/06/1982SE |
| K812830 | Apc Implantable Pacing LeadDTB · Traditional | 01/18/1982SE |
| K812807 | Apc Implantable Pacing LeadsDTB · Traditional | 01/18/1982SE |
| K810399 | Apc Implantabel Pacing Lead, Model 3264DTB · Traditional | 05/15/1981SE |
| K810398 | Apc Implantable Pacing Lead, Model 3266DTB · Traditional | 05/15/1981SE |
| K810397 | Apc Implantable Pacing Lead-Flange #3260DTB · Traditional | 05/15/1981SE |
| K810396 | Apc Implantable Pacing Lead, Tined #3262DTB · Traditional | 05/15/1981SE |
| K810121 | Unifocal 3DXY · Traditional | 02/23/1981SE |
| K800746 | Unifocal VP, Models 7501 and 7502DXY · Traditional | 12/16/1980SE |
| K800379 | Bifocal 2 8200 Series (A,B C,D)DXY · Traditional | 09/26/1980SE |
Questions and answers
When was Unifocal 3-2 Models Unipolar & Bipolar cleared by the FDA?
Unifocal 3-2 Models Unipolar & Bipolar (K792232) received a 510(k) decision of Substantially Equivalent on November 27, 1979, 22 days after the submission was received.
What is the product code of K792232?
The FDA product code is DXY – Implantable Pacemaker Pulse-Generator, a Class III (high risk) device regulated under 21 CFR 870.3610.