Permanent Pacing Leads PYBJ Series
510(k) K882345
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK882345 | Date28 Oct 1988 | 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- Withdrawn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
The Permanent Pacing Leads PYBJ Series is a class III medical device classified under the FDA’s regulation number 870.3680 as a Permanent Pacemaker Electrode. These leads are designed to interface with implantable pacemakers, providing electrical stimulation to regulate heart rhythm in patients with bradycardia or other conduction disorders. Constructed for long-term use, they are intended for chronic cardiac pacing applications within the cardiovascular system.
The PYBJ Series leads are supplied sterile and intended for single-use implantation. They are compatible with MRI environments under specific conditions as outlined in the device labeling, with various sizes and configurations available to accommodate different patient anatomies and pacing requirements. Authorized under FDA 510(k) clearance (K882345), these leads are regulated as a traditional submission and must be implanted by qualified healthcare professionals in controlled clinical settings. Sterility is maintained via gamma irradiation, and storage instructions are detailed in the accompanying documentation.