# K022238: Myocardial Lead Implant Tool, Model 10626

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Vascular
- Decided: Oct 9, 2002 after 90 days
- Product code: DWS (Instruments, Surgical, Cardiovascular)
- Device class: 1
- Regulation: 21 CFR 870.4500
- 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) Implant tool currently packaged with the Model 5071 lead: named in the summary without a submission number

## Indications for use
The Medtronic Model 10626 Myocardial Implant Tool is used to facilitate myocardial pacing lead placement. It is designed to assist in the placement and manipulation of the Model 5071 myocardial pacing lead.

Source page: https://510kreport.com/device/K022238
Methodology: https://510kreport.com/methodology