# K221886: Sublime Microcatheter

- Pathway: 510(k) (Traditional)
- Applicant: Surmodics,Inc.
- Decided: Oct 14, 2022 after 107 days
- Product code: DQY (Catheter, Percutaneous)
- Device class: 2
- Regulation: 21 CFR 870.1250
- 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 K052841 (2005). 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)
- K160884: CXI Support Catheter, Cook Incorporated (2016) Summary page 4.

## Indications for use
The SublimeTM Microcatheter is intended to access the peripheral vasculature in order to facilitate the placement and/or the exchange of guidewires. The Sublime Microcatheter is also intended to provide a conduit for the delivery of saline solutions or diagnostic contrast agents.

Source page: https://510kreport.com/device/K221886
Methodology: https://510kreport.com/methodology