CCS Maestro(R) II Series 200 Models 235 and 227 Cardiac Pacemaker
FDA 510(k) K950210 · Cardiac Control Systems, Inc.
510(k) numberK950210
Submission
- Device name
- CCS Maestro(R) II Series 200 Models 235 and 227 Cardiac Pacemaker
- Applicant
- Cardiac Control Systems, Inc.
Palm Coast, FL, US - Received
- January 19, 1995
- Decision date
- May 3, 1995
- Decision
- Substantially Equivalent - Subject to Tracking Reg. (ST)
- 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 |
|---|---|---|
| K971775 | Interim Av Shaped Temporary Pacing Catheter Model INT-AV610LDF · Traditional | 12/29/1997SE |
| K946188 | CCDS Maestro(R) II Series 200 Cadiac PacemakerDXY · Traditional | 05/15/1995ST |
| K923868 | CCS Maestro II Series 200 Cardiac PacemakerDXY · Traditional | 05/14/1993SE |
| K905824 | Maestro(R) Series 100/200 Cardiac S/Chamb PacemakeDXY · Traditional | 05/16/1991SE |
| K904941 | Maestro Series 100/200 Cardiac Single Chamber PaceDXY · Traditional | 01/03/1991SE |
| K895110 | Maestro Pacemaker Test MagnetDTG · Traditional | 09/26/1989SE |
| K884023 | Maestro(R) Series 100/200 Single Chamber PacemakerDXY · Traditional | 10/17/1988SE |
| K884024 | Polysafe(Tm) Implantable Pacing LeadDTB · Traditional | 10/14/1988SE |
| K883015 | Polysafe Implant. Pacing Leads W/Trabeculok TipDTB · Traditional | 10/06/1988SE |
| K883016 | Polysafe Implant. Pacing Leads W/Tined Fixa. TipDTB · Traditional | 09/16/1988SE |
Questions and answers
When was CCS Maestro(R) II Series 200 Models 235 and 227 Cardiac Pacemaker cleared by the FDA?
CCS Maestro(R) II Series 200 Models 235 and 227 Cardiac Pacemaker (K950210) received a 510(k) decision of Substantially Equivalent - Subject to Tracking Reg. on May 3, 1995, 104 days after the submission was received.
What is the product code of K950210?
The FDA product code is DXY – Implantable Pacemaker Pulse-Generator, a Class III (high risk) device regulated under 21 CFR 870.3610.