Pacing Lead Models SA 350, SAM 500 - SA

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K781619 ↗

FDA Product Code

DTB

Models / Variants

SA

350

Sam 500

Device Class

Class III

Regulation

21 CFR Part 870.3680

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Stilith Cardiac Pacemakers-M 60 & 120

  Class III

  FDA 510(k) K780781 Active Cleared 27 Jul 1978

• Pacing Lead Models MAM 1260 MAM 1290

  Class III

  FDA 510(k) K781621 Active Cleared 8 Dec 1978

• Pacing Lead Model Bus 860, Bus 890

  Class III

  FDA 510(k) K781624 Active Cleared 21 Dec 1978

• Pacing Lead Adapter, Acv 14, Acv 23

  Class II

  FDA 510(k) K781626 Active Cleared 8 Dec 1978

• Pacing Lead Models MDM 1060, MDM 1090

  Class III

  FDA 510(k) K781620 Active Cleared 8 Dec 1978

• Pacing Lead Model MVM 860, MVM 890

  Class III

  FDA 510(k) K781625 Active Cleared 8 Dec 1978

See all devices from R.E. Brown Co., Inc. →

• Are these pacing leads designed for reuse in multiple patients, or are they intended for single-use only?

  These leads (Models SA 350 and SAM 500) are supplied sterile and explicitly intended for single-use implantation in a hospital setting. The packaging and regulatory classification as Class III devices emphasize their sterile, one-time-use nature to ensure patient safety and compliance with medical device standards.

• What types of cardiac pacing systems are these leads compatible with, and how do I determine the correct model for my patient?

  The leads (SA 350 and SAM 500) are designed for compatibility with permanent pacemaker systems but come in specified configurations to match particular pacing needs. While the exact models aren’t detailed here, the manufacturer (R.E. Brown Co., Inc.) likely provides compatibility charts or clinical guidance to pair the lead with the appropriate pacemaker device. Always verify with the manufacturer or your device supplier to ensure proper fit for your patient’s pacing requirements.

• How should these leads be stored before use, and what are the key considerations for maintaining their sterility?

  Since these leads are sterile upon packaging, they must be stored in their original, unopened packaging to preserve sterility. The manufacturer’s instructions (not provided here) would specify environmental conditions like temperature and humidity, but generally, they should be kept in a clean, dry area away from direct sunlight or extreme temperatures. Avoid exposing them to moisture or contamination, as this could compromise their sterile status before implantation.

• What is the regulatory pathway these leads follow, and how does that affect their use in clinical practice?

  These leads were cleared via the FDA 510(k) Traditional review pathway under the product code DTB (Permanent Pacemaker Electrodes) and are classified as Class III devices (870.3680). This means they undergo rigorous pre-market evaluation to ensure safety and effectiveness for their intended use—delivering electrical stimulation to the heart for cardiac pacing. Clinically, this clearance ensures they meet FDA standards for use in hospital settings by cardiologists, though local hospital protocols and physician training should still govern their specific application.