Model 329-701 Bipolar Active-Fixation Lead
by Telectronics and Cordis Pacing Systems
510(k) K883265
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK883265 | Date14 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- Withdrawn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 Model 329-701 Bipolar Active-Fixation Lead is a Permanent Pacemaker Electrode, designed for implantation in the cardiovascular system. It delivers electrical stimulation to regulate heart rhythm in patients with bradycardia or other cardiac conduction disorders. The device features bipolar electrodes for precise pacing and active-fixation tines to ensure stable lead positioning within the heart chamber.
This lead is intended for single-use implantation in cardiac pacing procedures and is classified as a Class III device under FDA regulation 870.3680. It is supplied sterile and requires surgical placement within the body, typically within a cardiac pacing system. The device holds an FDA 510(k) clearance (K883265) under the Traditional pathway, with a decision of Substantially Equivalent (SESE) issued in 1988. No additional regulatory markings or MRI safety classifications are specified.