Tools, Pacemaker Service
Pacemaker Service Tools are cardiovascular accessories used by clinicians or technicians to implant, adjust, repair, or service pacemaker systems, including specialized instruments required for lead placement, connector engagement, or device programming during cardiac device procedures. They are classified as FDA Class 1 devices, representing the lowest level of regulatory concern, and are subject to general controls only. The product code is DTF and these tools are regulated under 21 CFR 870.3730 within the Cardiovascular medical specialty.
Research product code DTF in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- DTF
- Device Class
- FDA class 1
- Regulation Number
- 870.3730
- 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 2 510(k) clearances via K numbers.
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.