Biopore VS.1 Endocardial Inter Implant Pacing Lead

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

510(k) Number

K883602 ↗

FDA Product Code

DTB

Device Class

Class III

Regulation

21 CFR Part 870.3680

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Lifeline Unipolar Lead #487-05

  Class III

  FDA 510(k) K823508 Active Cleared 14 Jan 1983

• Implant Aid Splicing Crimp & Sleeve

  Class III

  FDA 510(k) K813518 Active Cleared 12 Jan 1982

• Veri-Vu Lensometer

  Class I

  FDA 510(k) K791521 Active Cleared 30 Oct 1979

• Implantable Pulse Generator Pacemakers

  Class III

  FDA 510(k) K791568 Active Cleared 19 Sep 1979

• Model 480-01 Pacing Lead

  Class III

  FDA 510(k) K844270 Active Cleared 28 Mar 1985

• GE Lead Adapter, Model 345-01

  Class II

  FDA 510(k) K801040 Active Cleared 30 Jun 1980

See all devices from Intermedics, Inc. →

• What is the Biopore VS.1 Endocardial Interim Implant Pacemaker Lead used for in clinical practice?

  The Biopore VS.1 is designed for temporary or interim endocardial pacing, meaning it delivers electrical stimulation to the heart muscle to maintain proper rhythm when a patient needs short-term support. This could include bridging to a permanent pacemaker system or aiding recovery after cardiac procedures. It is implanted directly into the heart chamber by qualified professionals in controlled settings like catheterization labs or operating rooms.

• Is the Biopore VS.1 lead single-use or reusable, and how should it be handled?

  The Biopore VS.1 is sterile and intended for single-use only. Due to its classification as a Class III device and its role in cardiac rhythm management, it must be handled with strict sterile techniques to prevent infection. Discard after one use and follow manufacturer guidelines for disposal.

• What regulatory pathway does the Biopore VS.1 follow, and how does that affect its use?

  The Biopore VS.1 was cleared via an FDA 510(k) pathway (K883602) under the permanent pacemaker electrode category (DTB). This means it was deemed substantially equivalent to a legally marketed device at the time of clearance, ensuring it meets FDA safety and performance standards for endocardial pacing leads. Clinicians should confirm compliance with the latest FDA and manufacturer guidelines for proper use.

• Are there multiple sizes or models of the Biopore VS.1, and how would I identify the correct one for a patient?

  The provided data lists multiple FEI numbers (e.g., 3002618605, 1028232) associated with the Biopore VS.1, which may correspond to different lot or batch identifiers rather than distinct sizes or models. For precise sizing, refer to the manufacturer’s specifications or consult with a cardiologist, as lead selection depends on patient anatomy (e.g., heart chamber dimensions) and procedural requirements. Always verify compatibility with the patient’s specific needs.

• How should the Biopore VS.1 be stored before use, and what are the key considerations?

  While the data doesn’t specify storage conditions explicitly, as a sterile, single-use medical device, the Biopore VS.1 should be stored in its original packaging in a clean, dry environment away from direct sunlight or extreme temperatures. Check the packaging for expiration dates or storage instructions, and ensure it remains unopened until immediate preoperative use to maintain sterility and functionality.