# K131401: Blowfish Transbronchial Micro-Infusion Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Mercator Medsystems, Inc.
- Decided: Jul 2, 2013 after 48 days
- Product code: EOQ (Bronchoscope (Flexible Or Rigid))
- Device class: 2
- Regulation: 21 CFR 874.4680
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K096901: Olympus BS-2C/87-2C Balloon Catheter. Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
The BlowfishTM Transbronchial Micro-Infusion Catheter is intended to deliver therapeutic and diagnostic agents that are indicated or labeled for airway, tracheal or bronchial delivery into selected and sub-selected regions of the airway tree.

Source page: https://510kreport.com/device/K131401
Methodology: https://510kreport.com/methodology