# K901502: Amplatz Goose-Neck Snare

- Pathway: 510(k) (Traditional)
- Applicant: Microvena Corp.
- Decided: Dec 3, 1990 after 249 days
- Product code: DXE (Catheter, Embolectomy)
- Device class: 2
- Regulation: 21 CFR 870.5150
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
47 later devices descend from it; 1 cites it directly.
4 of 48 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
- K972511: Amplatz Goose Neck Snare Kit/ Catheter (1998), 46 descendants of its own
- K021441: Radius Snare (2002), 36 descendants of its own
- K022201: Radius Micro Snare (2003), 32 descendants of its own
- K032426: Gunhter Tulip Vena Cava Mreye Filter and Retrieval Set (2003), 31 descendants of its own
- K073374: Cook Clect Vena Cava Filter, Gunther Tulip Vena Cava Filter Retrieval Set (2008), 16 descendants of its own

## Recalls of this device
- Aug 16, 2005 · Not classified · Z-0894-06: ev3 has determined that one test unit from each of two lots did not meet mininum tensile strength requirements and therefore the entire lots are being recalled.

Source page: https://510kreport.com/device/K901502
Methodology: https://510kreport.com/methodology