# K162500: Ostial Sprit Cannulae

- Pathway: 510(k) (Traditional)
- Applicant: Spyder Medical
- Decided: Jan 12, 2017 after 127 days
- Product code: DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4210
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K030231 (2003). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030231: Coronary Artery Perfusion Cannula with Self-Inflating Balloon, Sorin Group Italia S.R.L. (2003) Summary page 4.

## Indications for use
Spyder Medical’s Ostial Sprit Cannulae is indicated for use in delivery of cardioplegia solution directly to the coronary arteries during cardiopulmonary bypass surgery.

Source page: https://510kreport.com/device/K162500
Methodology: https://510kreport.com/methodology