# K190401: MAMBA and MAMBA Flex Microcatheters

- Pathway: 510(k) (Special)
- Applicant: Boston Scientific Corporation
- Decided: Mar 15, 2019 after 24 days
- Product code: DQY (Catheter, Percutaneous)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K171452 (2017). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171452: MAMBA and MAMBA FLEX Microcatheters, Boston Scientific Corporation (2017) Summary page 4.

## Recalls of this device
- Mar 5, 2021 · Class II · Z-1429-2021: The firm initiated a removal of certain batches of MAMBA 135 and MAMBA Flex 135 Microcatheters due to incorrect labeling and packaging.
- Mar 5, 2021 · Class II · Z-1430-2021: The firm initiated a removal of certain batches of MAMBA 135 and MAMBA Flex 135 Microcatheters due to incorrect labeling and packaging.

## Indications for use
The MAMBA and MAMBA Flex Microcatheters are intended to provide support to facilitate the placement of guidewires in the coronary vasculature, and can be used to exchange one guidewire for another. The microcatheters are also intended to assist in the delivery of contrast media into the coronary vasculature.

Source page: https://510kreport.com/device/K190401
Methodology: https://510kreport.com/methodology