Maestro Pacemaker Test Magnet
FDA 510(k) K895110 · Cardiac Control Systems, Inc.
510(k) numberK895110
Submission
- Device name
- Maestro Pacemaker Test Magnet
- Applicant
- Cardiac Control Systems, Inc.
Palm Coast, FL, US - Received
- August 15, 1989
- Decision date
- September 26, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DTG – Magnet, Test, Pacemaker
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 870.3690
- Specialty
- Cardiovascular
Other 510(k)s with product code DTG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K092364 | Model 220 Patient MagnetDTG · Traditional | Cyberonics, Inc. | 11/03/2009SE |
| K960849 | Magno AlarmDTG · Traditional | Cardiac Assist Devices, Inc. | 03/26/1997SE |
| K831926 | Implantable Endocardial Pacing LeadsDTG · Traditional | Oscor, Inc. | 03/12/1984SE |
| K813153 | Test MagnetDTG · Traditional | Pacesetter Systems | 12/02/1981SE |
More from Pacesetter Systems
| 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 |
| 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 |
| 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 Maestro Pacemaker Test Magnet cleared by the FDA?
Maestro Pacemaker Test Magnet (K895110) received a 510(k) decision of Substantially Equivalent on September 26, 1989, 42 days after the submission was received.
What is the product code of K895110?
The FDA product code is DTG – Magnet, Test, Pacemaker, a Class I (low risk) device regulated under 21 CFR 870.3690.