# K092177: MO.MA Ultra Proximal Cerebral Protection Device, Model MUS0130069X6

- Pathway: 510(k) (Traditional)
- Applicant: Invatec S.P.A.
- Decided: Oct 15, 2009 after 86 days
- Product code: NTE (Temporary Carotid Catheter For Embolic Capture)
- Device class: 2
- Regulation: 21 CFR 870.1250
- 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 K003992 (2001). 28 ancestors in all.
No later device cites it as a predicate yet.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083300: Gore Flow Reversal System, W. L. Gore & Associates, Inc. (2009) Summary page 1.

## Recalls of this device
- Oct 12, 2023 · Class II · Z-0320-2024: The Mo.Ma Ultra device manifold is labelled with 2 stickers, an inferior and superior sticker, one on each side of the manifold. These stickers label the common carotid artery (CCA) proximal balloon a
- Oct 12, 2023 · Class II · Z-0321-2024: The Mo.Ma Ultra device manifold is labelled with 2 stickers, an inferior and superior sticker, one on each side of the manifold. These stickers label the common carotid artery (CCA) proximal balloon a
- Oct 12, 2023 · Class II · Z-0322-2024: The Mo.Ma Ultra device manifold is labelled with 2 stickers, an inferior and superior sticker, one on each side of the manifold. These stickers label the common carotid artery (CCA) proximal balloon a

## Indications for use
The MO.MA® ULTRA Proximal Cerebral Protection Device is indicated as an embolic protection system to contain and remove embolic material (thrombus/debris) while performing angioplasty and stenting procedures involving lesions of the internal carotid artery and or the carotid bifurcation. The reference diameter of the external carotid artery should be between 3-6 mm and the reference diameter of the common carotid artery should be between 5-13 mm.

Source page: https://510kreport.com/device/K092177
Methodology: https://510kreport.com/methodology