Pacing Models Mum 860, Mum 890

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K781623 ↗

FDA Product Code

DTB

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 the Mum 860 and Mum 890 pacemaker electrodes designed for reuse in clinical settings, or are they intended for single-use only?

  The Mum 860 and Mum 890 pacemaker electrodes are explicitly supplied sterile and intended for single-use implantation only. This is clearly stated in the device description, ensuring they meet clinical standards for sterile, one-time-use medical devices.

• What types of heart conditions or arrhythmias are these electrodes intended to address, and how do they function?

  These electrodes are permanent pacemaker electrodes designed to regulate abnormal heart rhythms by delivering electrical impulses to the heart muscle. They ensure proper pacing and synchronization of cardiac contractions, which is critical for patients with bradycardia or other conduction disorders requiring chronic rhythm management.

• How are these devices classified under FDA regulations, and what was the review process for their clearance?

  The Mum 860 and Mum 890 are classified as Class III medical devices under FDA regulations, requiring a 510(k) clearance through a traditional review process. They were reviewed by the Cardiovascular Advisory Committee and granted clearance under the Federal Device Code 870.3680, with a decision of *Substantially Equivalent* (SESE).

• What storage or handling precautions should be taken for these electrodes before implantation?

  Since the electrodes are supplied sterile, they must be stored in their original packaging until use to maintain sterility. As they are intended for single-use, they should not be reused or restocked after opening. Proper sterile field protocols should be followed during implantation to prevent contamination.