CCDS Maestro(R) II Series 200 Cadiac Pacemaker
FDA 510(k) K946188 · Cardiac Control Systems, Inc.
510(k) numberK946188
Submission
- Device name
- CCDS Maestro(R) II Series 200 Cadiac Pacemaker
- Applicant
- Cardiac Control Systems, Inc.
Palm Coast, FL, US - Received
- December 20, 1994
- Decision date
- May 15, 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 |
| K950210 | CCS Maestro(R) II Series 200 Models 235 and 227 Cardiac PacemakerDXY · Traditional | 05/03/1995ST |
| 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 CCDS Maestro(R) II Series 200 Cadiac Pacemaker cleared by the FDA?
CCDS Maestro(R) II Series 200 Cadiac Pacemaker (K946188) received a 510(k) decision of Substantially Equivalent - Subject to Tracking Reg. on May 15, 1995, 146 days after the submission was received.
What is the product code of K946188?
The FDA product code is DXY – Implantable Pacemaker Pulse-Generator, a Class III (high risk) device regulated under 21 CFR 870.3610.