# K960983: Medtronic Everst 30 Inflation Device/Survival Kit

- Pathway: 510(k) (Traditional)
- Applicant: Medtronics Interventional Vascular
- Decided: May 30, 1996 after 80 days
- Product code: MAV (Syringe, Balloon Inflation)
- Device class: 2
- Regulation: 21 CFR 870.1650
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K153038: Everest 20 Disposable Inflation Device, Everest 20 Survival Kit, Everest 30 Disposable Inflation Device, Everest 30 Survival Kit (2016), 1 descendant of its own
- K220773: Everest 20 Inflation Device and 3-way Stopcock (AC2200);Everest 30 Inflation Device and 3-way Stopcock (AC3200);Everest 20 Survival Kit containing:1. Everest 20 Device with 3-way Stopcock, 2. Piton Y-Adaptor ,3. Metal Guidewire Insertion Needle, 4. Torque Handle  (AC2205P); Everest 30 Survival Kit containing:1. Everest 30 Device with 3-way Stopcock, 2. Piton Y-Adaptor,3. Metal Guidewire Insertion Needle,  4. Torque Handle (AC3205P) (2022), 0 descendants of its own

## Recalls of this device
- 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.

## Indications for use
The Indications for the Medtronic® Everest™ 30 Inflation Device / Survival Kit are identical to those for commercially available inflation devices. The devices are used for the inflation / deflation of balloon dilatation catheters. These devices are intended for single use.

Source page: https://510kreport.com/device/K960983
Methodology: https://510kreport.com/methodology