Implantable Pacing Lead CCS Model SV-101

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

510(k) Number

K830828 ↗

FDA Product Code

DTB

Device Class

Class III

Regulation

21 CFR Part 870.3680

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• CCS Implantable Maestro Series 100/200 Pacemaker

  Class III

  FDA 510(k) K874158 Active Cleared 29 Dec 1987

• Maestro Series 100/200 Single Chamber Pacemaker

  Class III

  FDA 510(k) K884023 Active Cleared 17 Oct 1988

• Maestro II Series 200 Models 235 and 227 Cardiac Pacemaker

  Class III

  FDA 510(k) K950210 Active Cleared 3 May 1995

• CCS Implantable Maestro 106/206/210 Cardiac Pacemaker

  Class III

  FDA 510(k) K853471 Active Cleared 24 Feb 1986

• CCS Model SJ-103 Implantable Atrial

  Class III

  FDA 510(k) K831529 Active Cleared 30 Jun 1983

• Maestro Series 100/200 Cardiac Single Chamber Pacemaker

  Class III

  FDA 510(k) K904941 Active Cleared 3 Jan 1991

See all devices from Cardiac Control Systems, Inc. →

• What is the Implantable Pacing Lead CCS Model SV-101 used for in clinical practice?

  The Implantable Pacing Lead CCS Model SV-101 is designed for chronic cardiac pacing therapy, delivering electrical impulses to regulate heart rhythm and support cardiac function in patients who require long-term pacing support. It is specifically classified as a *Permanent Pacemaker Electrode* and is intended for use in cardiovascular procedures where stable, reliable pacing is necessary.

• Is the SV-101 lead single-use or reusable, and how should it be handled?

  The SV-101 is sterile and intended for single-use only after implantation. Since it is a sterile medical device, it must be handled using aseptic techniques and stored according to sterile device protocols to prevent contamination before use. Reuse is not recommended or supported by the manufacturer.

• What regulatory pathway was followed for FDA clearance of this device?

  The SV-101 received FDA 510(k) clearance (K830828) under the *Traditional* review pathway, with a decision of *Substantially Equivalent (SESE)* to a predicate device. The submission was reviewed by the Cardiovascular (CV) Advisory Committee and classified under regulation 870.3680 for Permanent Pacemaker Electrodes. This clearance confirms its compliance with U.S. safety and performance standards for cardiovascular devices.

• Are there multiple sizes or models of the SV-101, or is it a single standardized lead?

  The provided data does not specify variations in sizes or models for the SV-101 itself, but it is listed under OpenFDA registration numbers that include multiple lot/serial identifiers (e.g., 3002618605, 3008377825), which may correspond to different production batches rather than distinct lead configurations. For exact sizing or model variations, consult the manufacturer’s technical documentation or catalog.

• How should the SV-101 be stored to maintain its sterility and functionality?

  As a sterile, single-use device, the SV-101 must be stored in its original, unopened packaging in a clean, dry environment protected from moisture, extreme temperatures, and direct sunlight. Follow the manufacturer’s instructions for shelf life and storage conditions, typically outlined in the accompanying documentation, to ensure sterility and performance integrity until implantation.