# K131437: Modified Concentric Microcatheter

- Pathway: 510(k) (Traditional)
- Applicant: Concentric Medical, Inc.
- Decided: Oct 11, 2013 after 144 days
- Product code: DQO (Catheter, Intravascular, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 870.1200
- 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: 4 generations back to K003086 (2001). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113260: Modified Concentirc Microcatheter, Concentric Medical, Inc. (2012) Summary page 1.

## Recalls of this device
- Apr 23, 2024 · Class II · Z-1904-2024: Neurovascular devices did not meet the minimum sample size required for endotoxin testing during manufacturing processes and are out of compliance with the AAMI ST72 standard, so these devices may exc
- Dec 6, 2023 · Class II · Z-1084-2024: The microcatheter IFU contains an intended use that has not been evaluated by the FDA.

## Indications for use
The Modified Concentric Microcatheter is indicated for use in the selective placement of fluids and/or other devices or agents into the peripheral, coronary and neuro vasculature during diagnostic and/or therapeutic procedures.

Source page: https://510kreport.com/device/K131437
Methodology: https://510kreport.com/methodology