# K111644: Mobicath Transseptal Needle

- Pathway: 510(k) (Traditional)
- Applicant: Great Batch Medical
- Decided: Oct 3, 2011 after 112 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
Longest line of descent: 5 generations back to K964518 (1997). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072278: BRK Transseptal Needle, St Jude Medical (2007)
- K011727: Transseptal Needle/Trocar, Thomas Medical Products, Inc. (2002)

## 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/K111644
Methodology: https://510kreport.com/methodology