UNIVERSAL TERMINAL CAP, 3.2MM
Device Facts
| Record ID | K913919 |
|---|---|
| Device Name | UNIVERSAL TERMINAL CAP, 3.2MM |
| Applicant | Telectronics Pacing Systems, Inc. |
| Product Code | KFJ · Cardiovascular |
| Decision Date | Dec 31, 1991 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.3710 |
| Device Class | Class 3 |
Regulatory Classification
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.
