DTG · Magnet, Test, Pacemaker
Cardiovascular · 21 CFR 870.3690 · Class 1
Overview
| Product Code | DTG |
|---|---|
| Device Name | Magnet, Test, Pacemaker |
| Regulation | 21 CFR 870.3690 |
| Device Class | Class 1 |
| Review Panel | Cardiovascular |
Identification
A pacemaker test magnet is a device used to test an inhibited or triggered type of pacemaker pulse generator and cause an inhibited or triggered generator to revert to asynchronous operation.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
Recent Cleared Devices (5 of 5)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K092364 | MODEL 220 PATIENT MAGNET | Cyberonics, Inc. | Nov 3, 2009 | SESE |
| K960849 | MAGNO ALARM | Cardiac Assist Devices, Inc. | Mar 26, 1997 | SESE |
| K895110 | MAESTRO PACEMAKER TEST MAGNET | Cardiac Control Systems, Inc. | Sep 26, 1989 | SESE |
| K831926 | IMPLANTABLE ENDOCARDIAL PACING LEADS | Oscor, Inc. | Mar 12, 1984 | SESE |
| K813153 | TEST MAGNET | Pacesetter Systems | Dec 2, 1981 | SESE |
Top Applicants
- Cardiac Assist Devices, Inc. — 1 clearance
- Cardiac Control Systems, Inc. — 1 clearance
- Cyberonics, Inc. — 1 clearance
- Oscor, Inc. — 1 clearance
- Pacesetter Systems — 1 clearance
