# K121677: Surefire HI-Flow Microcatheter

- Pathway: 510(k) (Traditional)
- Applicant: Surefire Medical, Inc.
- Decided: Jun 14, 2012 after 7 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: 3 generations back to K003105 (2001). 5 ancestors in all.
7 later devices descend from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110459: Surefire Infusion Catheter System, Surefire Medical, Inc. (2011)

## Most influential descendants
- K143588: Surefire Infusion System 021 (2015), 6 descendants of its own
- K160662: Surefire Infusion System (2016), 5 descendants of its own
- K171355: Surefire Precision Infusion System (2017), 4 descendants of its own
- K180677: Surefire Spark Infusion System (2018), 2 descendants of its own
- K230957: TriSalus TriNav® LV Infusion System (2023), 1 descendant of its own

## Indications for use
The SUREFIRE' HI-FLOW MICROCATHETER is intended for use in angiographic procedures. It delivers radiopaque media and therapeutic agents to selected sites in the peripheral vascular system.

Source page: https://510kreport.com/device/K121677
Methodology: https://510kreport.com/methodology