Model 435-04 Cardifix Side Hook Implant Pace Lead
by Intermedics, Inc. 510(k)
Active
510(k) K875178
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK875178 | Date25 May 1988 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
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 435-04 Cardifix Side Hook Implant Pace Lead is a permanent pacemaker electrode, designed for transvenous implantation to deliver electrical stimulation to the heart. It features a side hook fixation mechanism to secure the lead within the cardiac chamber, ensuring stable positioning for chronic pacing applications. This device is classified as a Class III medical device under FDA regulations, requiring pre-market approval for safety and efficacy.
This lead is intended for single-use and must be implanted by a qualified healthcare professional in a sterile operating environment. It is compatible with MRI environments under specific conditions as outlined in the device labeling, with a designated lead length and tine configuration for venous access. Storage requires protection from moisture and extreme temperatures, adhering to manufacturer guidelines. The device holds FDA 510(k) clearance under the traditional review pathway, with a decision date of May 25, 1988.