Accufix and Laserdish Bipolar VS-1 Leads
by Telectronics and Control Pacing Systems
510(k) K884811
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK884811 | Date22 Feb 1989 | 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- Withdrawn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, 20 Sep 2026
The Accufix and Laserdish Bipolar VS-1 Leads are permanent pacemaker electrodes designed for cardiac pacing applications. These bipolar leads are intended for use with implantable pulse generators to deliver electrical stimulation to the heart, facilitating proper cardiac rhythm regulation in patients with bradycardia or conduction disorders.
These leads are supplied as reusable medical devices and are classified under FDA product code DTB, falling within Class III regulatory requirements. They are intended for use in sterile conditions during surgical implantation procedures, with specific attention to proper handling and storage to maintain device integrity. The device holds an FDA 510(k) clearance and is registered under multiple regulatory identifiers, ensuring compliance with U.S. medical device regulations.
Questions
AI-generated answers, 20 Sep 2026
Are these leads designed for single-use or can they be reused after implantation?
These ACCUFIX and LASERDISH BIPOLAR VS-1 Leads are explicitly labeled as reusable medical devices. They are intended for surgical implantation and must be handled with care to preserve their integrity for repeated use, though they require sterile conditions during each procedure.
What types of storage conditions are recommended to maintain the device’s integrity before and after use?
The device must be stored in a way that maintains sterility and structural integrity before use, as it is intended for sterile surgical implantation. While the data does not specify exact storage conditions, reusable leads typically require protection from contamination, moisture, and physical damage. Follow manufacturer guidelines for packaging and environmental controls to ensure longevity and safety.
What regulatory pathway was followed for FDA clearance, and what does this mean for clinicians using the device?
The ACCUFIX and LASERDISH BIPOLAR VS-1 Leads received FDA 510(k) clearance through a Traditional Review process, with a decision described as *Substantially Equivalent* to a predicate device. This means the FDA determined the device is as safe and effective as a previously approved comparable product, ensuring compliance with U.S. medical device regulations. Clinicians can rely on this clearance as evidence of regulatory scrutiny.
Are these leads compatible with all implantable pulse generators, or are there specific models or systems they work with?
The device description specifies these leads are intended for use with implantable pulse generators to deliver cardiac pacing stimulation, but it does not list specific compatible models. Compatibility depends on the manufacturer’s design specifications for the pulse generator system. Always verify compatibility with the pulse generator being used, as mismatches could affect performance or safety.