# K041650: Micro Prime

- Pathway: 510(k) (Traditional)
- Applicant: Innovx Medical, Inc.
- Decided: Aug 16, 2004 after 60 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: 2 generations back to K803277 (1981). 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)
- K024069: One Piece Pediatric Arterial Cannula, Model: 77006, 77106, Medtronic Vascular (2003) Summary page 1.
- K803277: Tygon Tubing, Electromedics, Inc. (1981) Summary page 1.
- K964205: Better-Tubing, Circulatory Technology, Inc. (1998) Summary page 1.

## Indications for use
Micro Prime Delivery Lines are indicated for use to convey arterial blood and cardioplegia with minimal prime volume in the extracorporeal circuit.

Source page: https://510kreport.com/device/K041650
Methodology: https://510kreport.com/methodology