MPC Model 7000 External Temporary Pacemaker System
510(k) K970347
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK970347 | Date29 Aug 1997 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- DTE
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.3600
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The MPC Model 7000 External Temporary Pacemaker System is a pulse-generator device designed for temporary cardiac pacing. It delivers electrical impulses to regulate heart rhythm in patients experiencing bradycardia or other temporary conduction disorders, ensuring short-term cardiac support until permanent solutions can be implemented.
This system is intended for use in hospital settings and is classified as a Class II device under FDA regulation 870.3600. It is supplied as a reusable external device, with no indication of sterility requirements in the regulatory data. The system has received FDA 510(k) clearance (K970347) under the traditional clearance type, with a decision date of August 29, 1997. No MRI safety information or specific size variations are noted in the available data.