VS-1 Silicone Implant Leads (New Serial Number Tube)

No FDA recalls found in the data synced 22 Oct 2026.

Full name

Vs-1 Silicone Implant Leads (New Serial # Tube)

510(k) Number

K890350 ↗

FDA Product Code

DTB

Device Class

Class III

Regulation

21 CFR Part 870.3680

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Slimline Unipolar Endocardial Pacing Lead, 030-438

  Class III

  FDA 510(k) K865098 Active Cleared 18 Aug 1987

• Model 030-437 Implant Electrode

  Class III

  FDA 510(k) K870610 Active Cleared 20 Mar 1987

• Sterile Packaging

  Class III

  FDA 510(k) K810410 Active Cleared 5 Mar 1981

• Implantable Programmable Bipolar Cardiac (K800573)

  Class III

  FDA 510(k) K800573 Active Cleared 25 Mar 1980

• Laserpor Ap Atrial Endocard. Electr. Ld.

  Class III

  FDA 510(k) K820121 Active Cleared 12 Feb 1982

• Electrode, Model 030-324

  Class II

  FDA 510(k) K781822 Active Cleared 8 Feb 1979

See all devices from Telectronics, Inc. →

• Are these leads reusable or designed for single-use only, and how should they be handled to maintain sterility?

  The VS-1 Silicone Implant Leads are explicitly intended for single-use only. They must be handled under sterile conditions due to their classification as a sterile medical device. Since they come in a new serial number tube, they should remain unopened until immediate use and be discarded after implantation to prevent contamination or cross-infection.

• What types of patients or clinical scenarios are these leads intended for, and how do they function?

  These leads are designed for patients requiring pacing support to regulate abnormal heart rhythms. They are permanent pacemaker electrodes implanted within the cardiovascular system to deliver electrical stimulation to the heart, ensuring proper cardiac rhythm. They are used in conjunction with pacemaker systems for patients with conditions like bradycardia or heart block.

• Can these leads be used in an MRI environment, and if not, what precautions should be taken?

  The VS-1 Silicone Implant Leads are not MRI-safe. Patients with these leads implanted should avoid MRI procedures unless specifically cleared by a radiologist or cardiologist, as the magnetic fields could cause interference, damage, or displacement of the lead. Always confirm compatibility with the MRI facility before any imaging.

• How should these leads be stored to ensure they remain effective and sterile until use?

  These leads must be stored according to the manufacturer’s instructions to maintain integrity and sterility. They should be kept in their original sealed packaging, protected from moisture, extreme temperatures, and physical damage. Avoid exposure to direct sunlight or contaminants, and ensure the tube remains intact until immediate pre-procedure use.

• What regulatory pathway was followed for clearance of these leads, and which advisory committee was involved?

  The VS-1 Silicone Implant Leads received traditional 510(k) clearance through the FDA’s Cardiovascular (CV) Advisory Committee. The submission was classified as substantially equivalent (SESE) under the Permanent Pacemaker Electrode category (product code: DTB), with a decision date of February 2, 1989. This clearance confirms compliance with FDA Class III requirements for high-risk medical devices.