# K122832: Mobicath Transseptal Needle

- Pathway: 510(k) (Special)
- Applicant: Great Batch Medical
- Decided: Dec 19, 2012 after 93 days
- Product code: DRC (Trocar)
- Device class: 2
- Regulation: 21 CFR 870.1390
- 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 summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K111644: Mobicath Transseptal Needle, Great Batch Medical (2011). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
The MobiCath Transseptal Needle is used to create the primary puncture in the inter-atrial septum to facilitate the passing of an introducer or catheter through the septum from the right side of the heart to the left side.

Source page: https://510kreport.com/device/K122832
Methodology: https://510kreport.com/methodology