Magnet, Test, Pacemaker
The Pacemaker Test Magnet is a cardiovascular accessory device placed over an implanted pacemaker to temporarily switch the device into a fixed-rate, asynchronous pacing mode, allowing clinicians to assess pacemaker function and battery status without programming equipment. It is classified as an FDA Class 1 device, representing the lowest level of regulatory concern, and is subject to general controls only. The product code is DTG and it is regulated under 21 CFR 870.3690 within the Cardiovascular medical specialty.
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Basic Information
- Product Code
- DTG
- Device Class
- FDA class 1
- Regulation Number
- 870.3690
- Medical Specialty
- Cardiovascular
- Review Panel
- CV
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 5 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K092364 | MODEL 220 PATIENT MAGNET | Nov 03, 2009 | Substantially Equivalent | Cyberonics, Inc. |
| K960849 | MAGNO ALARM | Mar 26, 1997 | Substantially Equivalent | Cardiac Assist Devices, Inc. |
| K895110 | MAESTRO PACEMAKER TEST MAGNET | Sep 26, 1989 | Substantially Equivalent | Cardiac Control Systems, Inc. |
| K831926 | IMPLANTABLE ENDOCARDIAL PACING LEADS | Mar 12, 1984 | Substantially Equivalent | Oscor, Inc. |
| K813153 | TEST MAGNET | Dec 02, 1981 | Substantially Equivalent | Pacesetter Systems |
FEI Numbers
This FDA classification entry is associated with 6 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 6 registration numbers. Click on an entry to view related FDA registrations.