# K101784: Mobicath BI-Directional Guiding Sheath Model 1000182-XXX

- Pathway: 510(k) (Traditional)
- Applicant: Great Batch Medical
- Decided: Nov 26, 2010 after 154 days
- Product code: DYB (Introducer, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1340
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K893658 (1989). 43 ancestors in all.
No later device cites it as a predicate yet.
0 of 44 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083402: Agilis  NXT Steerable Introducer, Model G408322 and G408323, St Jude Medical (2008) Summary page 2.
- K061119: Enpath Medical Steerable Sheath, Enpath Medical, Inc. (2006) Summary page 2.

## Recalls of this device
- Sep 19, 2016 · Class II · Z-2914-2016: FDA inspection found that customers who had received devices with promotional material with outside use indications were not notified when labeling was revised to remove these indications.
- Nov 12, 2012 · Class II · Z-0611-2013: Greatbatch Medical observed some anomalies of the inner lumen of the MobiCath Bi-Directional Guiding Sheaths upon implementation of a new visual inspection tool. The anomalies may include loose, strin
- Sep 24, 2012 · Class II · Z-0132-2013: We are notifying you of a potential interaction between therapeutic catheters and MobiCath Bi-Directional Guiding Sheaths. We became aware of these interactions while investigating recent complaints r

## Indications for use
The Bidirectional Guiding Sheath is intended for introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum.

Source page: https://510kreport.com/device/K101784
Methodology: https://510kreport.com/methodology