# K961936: Model 2188 Coronary Sinus Lead.

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Vascular
- Decided: Aug 15, 1996 after 87 days
- Product code: DTB (Permanent Pacemaker Electrode)
- Device class: 3
- Regulation: 21 CFR 870.3680
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Model 6992A coronary sinus lead: named in the summary without a submission number

## Indications for use
The Model 2188 coronary sinus lead is designed for atrial pacing and sensing in the coronary sinus. The lead has application where permanent atrial or dual-chamber pacing systems are indicated.

Source page: https://510kreport.com/device/K961936
Methodology: https://510kreport.com/methodology