# K942269: Medtronic Everest Inflation Device

- Pathway: 510(k) (Traditional)
- Applicant: Medtronics Interventional Vascular
- Decided: Oct 18, 1994 after 161 days
- Product code: MAV (Syringe, Balloon Inflation)
- Device class: 2
- Regulation: 21 CFR 870.1650
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
12 later devices descend from it; 2 cite 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)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K092174: Enabler-P Catheter System, Model 3000 (2009), 9 descendants of its own
- K121763: Multicross Support Catheter (2012), 8 descendants of its own
- K140910: Centercross Catheter (2014), 3 descendants of its own
- K152456: CenterCross Ultra Catheter (2016), 2 descendants of its own
- K143608: NovaCross Microcatheter (2015), 2 descendants of its own

## Recalls of this device
- Feb 6, 2014 · Class III · Z-1121-2014: Incorrect master label.
- Jul 16, 2010 · Not classified · Z-2271-2010: Product sterility may be compromised due to breach of package seal integrity.
- Jul 16, 2010 · Not classified · Z-2272-2010: Product sterility may be compromised due to breach of package seal integrity.
- Jul 16, 2010 · Not classified · Z-2273-2010: Product sterility may be compromised due to breach of package seal integrity.
- Jan 31, 2003 · Not classified · Z-0625-03: PTCA balloon catheter contains a pressure gauge that does not accurately reflect the pressure of the balloon

Source page: https://510kreport.com/device/K942269
Methodology: https://510kreport.com/methodology