Product Code: KFJ
FDA class 3
21 CFR 870.3710
Materials, Repair Or Replacement, Pacemaker
Cardiovascular
Pacemaker Repair or Replacement Materials are components and materials used to repair or replace parts of implanted cardiac pacemakers, intended to restore or maintain the function of a pacemaker system already in situ in a patient. It is classified as FDA Class 3, the highest risk category, reflecting the critical nature of cardiac pacing support; devices in this class require Premarket Approval (PMA), demonstrating a reasonable assurance of safety and effectiveness through clinical evidence. The product code is KFJ, regulated under 21 CFR 870.3710, within the Cardiovascular medical specialty. This device is an implant.
510(k)s
3
FEI Numbers
0
Registration Numbers
0
Unique Applicants
3
Years Active
10
Basic Information
- Product Code
- KFJ
- Device Class
- FDA class 3
- Regulation Number
- 870.3710
- Medical Specialty
- Cardiovascular
- Review Panel
- CV
- Submission Type
- 2
Device Characteristics
✗
GMP Exempt
✓
Implant
✗
Life Sustain/Support
✗
Third Party
—
Summary Malfunction Reporting
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K913919 | UNIVERSAL TERMINAL CAP, 3.2MM | Dec 31, 1991 | Substantially Equivalent | TELECTRONICS PACING SYSTEMS, INC. |
| K852236 | MEDTRONIC MODEL 5867-1A | Jul 11, 1985 | Substantially Equivalent | MEDTRONIC VASCULAR |
| K813518 | IMPLANT AID SPLICING CRIMP & SLEEVE | Jan 12, 1982 | Substantially Equivalent | INTERMEDICS, INC. |