# K964868: 2.9F Cragg-Mcnamara Valved Infusion Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Micro Therapeutics, Inc.
- Decided: May 20, 1997 after 167 days
- Product code: KRA (Catheter, Continuous Flush)
- Device class: 2
- Regulation: 21 CFR 870.1210
- 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 K940634 (1994). 1 ancestor in all.
41 later devices descend from it; 2 cite it directly.
0 of 43 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K940634: Micro Therapeutics Infusion Catheter, Micro Therapeutics, Inc. (1994) Summary page 1.

## Most influential descendants
- K041629: Lysus Infusion System (2004), 39 descendants of its own
- K042456: Lysus Infusion System (2004), 38 descendants of its own
- K051319: Lysus Infusion System (2005), 35 descendants of its own
- K052071: Lysus Infusion System (2005), 34 descendants of its own
- K060422: Lysus Infusion System (2006), 27 descendants of its own

## Indications for use
The 2.9F Cragg-McNamara™ Valved Infusion Catheter is intended to be used for the controlled selective infusion of physician specified pharmacological agents and radiopaque contrast media into the general vasculature. It is not intended for coronary, neurological, pediatric or neonatal use.

Source page: https://510kreport.com/device/K964868
Methodology: https://510kreport.com/methodology