# K153125: IntraNovo Microcatheter

- Pathway: 510(k) (Special)
- Applicant: Texasmedical Technologies, Inc.
- Decided: Jan 13, 2016 after 76 days
- Product code: DQO (Catheter, Intravascular, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 870.1200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K915414 (1992). 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)
- K142817: IntraNovo 25 Microcatheter, Texasmedical Technologies, Inc. (2015) Summary page 4.

## Indications for use
The IntraNovo Microcatheter is intended for the infusion of contrast media into all peripheral vessels up to and including the cervical vessels, all vessels in the lower and upper extremities, and all coronary vessels. The Microcatheter is also intended for drug infusion in intra-arterial therapy and infusion of embolic materials for hemostasis. The Microcatheter should not be used in cerebral vessels.

Source page: https://510kreport.com/device/K153125
Methodology: https://510kreport.com/methodology