Model Ky Pacemaker Lead-Various, Modification
510(k) K913204
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK913204 | Date23 Sep 1991 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- DTB
- Device Class
- Class III
- Regulation
- 21 CFR Part 870.3680
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 18 Sep 2026
This device is a Permanent Pacemaker Electrode, classified as a Class III medical device under FDA regulations. It is designed to deliver electrical impulses to the heart for pacing purposes, ensuring proper heart rhythm in patients with bradycardia or conduction system disorders. The lead is intended for implantation within the cardiovascular system to stimulate cardiac tissue and maintain synchronous contractions.
The Model KY Pacemaker Lead is supplied in various lengths and configurations to accommodate different patient anatomies and surgical requirements. It is intended for single-use implantation and requires sterile handling prior to use. The device is compatible with multiple pacemaker systems and must be implanted using precise surgical techniques to ensure proper positioning and functionality. Authorized under FDA 510(k) clearance (K913204), it adheres to regulatory standards for cardiovascular devices, including those outlined in 21 CFR 870.3680.