Ceryx Pacemaker Models 114, 314 & 614
FDA 510(k) K854790 · Vitatron Medical BV
510(k) numberK854790
Submission
- Device name
- Ceryx Pacemaker Models 114, 314 & 614
- Applicant
- Vitatron Medical BV
Minneapolis, MN, US - Received
- November 29, 1985
- Decision date
- August 28, 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 |
|---|---|---|
| K844484 | Hewlett Packardt HP 85 W/ Vitatron PH1 Program HeaKRG · Traditional | 07/24/1985SE |
| K844485 | CERYX6, 611, Ceryx 3 311 & Ceryx 1 111KRG · Traditional | 04/19/1985SE |
| K844483 | TP 1KRG · Traditional | 04/19/1985SE |
| K840668 | Electrode Pacemaker, Perm & TempDTB · Traditional | 09/24/1984SE |
| K831860 | Generator, Pulse, Pacemaker #532DXY · Traditional | 10/27/1983SE |
| K831859 | Pacemaker Programmer #2032DXY · Traditional | 10/27/1983SE |
| K810928 | Endocardial ElectrodeDTB · Traditional | 07/02/1981SE |
| K791920 | Cardiac Pacemaker P4000 Ser. & P1000DXY · Traditional | 11/29/1979SE |
| K791921 | Cardiac Pacemaker C4000, C1000 Ser.DXY · Traditional | 10/26/1979SE |
| K791380 | Va 1000DTA · Traditional | 09/19/1979SE |
Questions and answers
When was Ceryx Pacemaker Models 114, 314 & 614 cleared by the FDA?
Ceryx Pacemaker Models 114, 314 & 614 (K854790) received a 510(k) decision of Substantially Equivalent on August 28, 1986, 272 days after the submission was received.
What is the product code of K854790?
The FDA product code is DXY – Implantable Pacemaker Pulse-Generator, a Class III (high risk) device regulated under 21 CFR 870.3610.