KFJ · Materials, Repair Or Replacement, Pacemaker
Cardiovascular · 21 CFR 870.3710 · Class 3
Overview
| Product Code | KFJ |
|---|---|
| Device Name | Materials, Repair Or Replacement, Pacemaker |
| Regulation | 21 CFR 870.3710 |
| Device Class | Class 3 |
| Review Panel | Cardiovascular |
| Implant | Yes |
Identification
A pacemaker repair or replacement material is an adhesive, a sealant, a screw, a crimp, or any other material used to repair a pacemaker lead or to reconnect a pacemaker lead to a pacemaker pulse generator.
Classification Rationale
Class III (premarket approval).
Recent Cleared Devices (3 of 3)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K913919 | UNIVERSAL TERMINAL CAP, 3.2MM | Telectronics Pacing Systems, Inc. | Dec 31, 1991 | SESE |
| K852236 | MEDTRONIC MODEL 5867-1A | Medtronic Vascular | Jul 11, 1985 | SESE |
| K813518 | IMPLANT AID SPLICING CRIMP & SLEEVE | Intermedics, Inc. | Jan 12, 1982 | SESE |
Top Applicants
- Intermedics, Inc. — 1 clearance
- Medtronic Vascular — 1 clearance
- Telectronics Pacing Systems, Inc. — 1 clearance
