Arcolith 2100-CARDIAC Pulse Generator
FDA 510(k) K792216 · Arco Medical Products Co.
510(k) numberK792216
Submission
- Device name
- Arcolith 2100-CARDIAC Pulse Generator
- Applicant
- Arco Medical Products Co.
Mchenry, IL, US - Received
- November 5, 1979
- Decision date
- November 29, 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 |
|---|---|---|
| K802588 | Model 3003 Unipolar Demand Cardiac Gen.DXY · Traditional | 11/19/1980SE |
| K801806 | External Silastic Boot for Cardiac PulseDXY · Traditional | 09/09/1980SE |
| K801241 | Unipolar Programmable Lithium Card. Gen.DXY · Traditional | 06/30/1980SE |
| K800837 | Programmable Bipolar Cardiac GeneratorDXY · Traditional | 06/30/1980SE |
| K800838 | Arcolith 3022&ARCOLITH 3023 Cardiac Gen.DXY · Traditional | 06/04/1980SE |
| K800326 | Arcolith 3021-CARDIAC Pulse GeneratorDXY · Traditional | 03/17/1980SE |
| K792299 | Arcolith 3020-CARDIAC Pulse GeneratorDXY · Traditional | 11/29/1979SE |
| K791715 | Arcolith 2000DXY · Traditional | 09/27/1979SE |
| K791147 | Arco Progammable Pacemaker SystemDXY · Traditional | 08/03/1979SE |
| K791165 | Arcolith 4000DXY · Traditional | 07/10/1979SE |
Questions and answers
When was Arcolith 2100-CARDIAC Pulse Generator cleared by the FDA?
Arcolith 2100-CARDIAC Pulse Generator (K792216) received a 510(k) decision of Substantially Equivalent on November 29, 1979, 24 days after the submission was received.
What is the product code of K792216?
The FDA product code is DXY – Implantable Pacemaker Pulse-Generator, a Class III (high risk) device regulated under 21 CFR 870.3610.