# K940189: Coil Positioner Set

- Pathway: 510(k) (Traditional)
- Applicant: Cook, Inc.
- Decided: Nov 28, 1994 after 319 days
- Product code: KRD (Device, Vascular, For Promoting Embolization)
- Device class: 2
- Regulation: 21 CFR 870.3300
- Recalls of this device: none
- 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; 3 cite it directly.
0 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
- K993455: Flipper Detachable Embolization Coil (2000), 41 descendants of its own
- K031810: Amplatzer Vascular Plug (2003), 38 descendants of its own
- K043371: Biomerix Vascular Occlusion Device and Loader (2005), 20 descendants of its own
- K070961: Biomerix Surgical Mesh, Model: RCR-01 (2008), 17 descendants of its own
- K071125: Amplatzer Vascular Plug II Models: AVP2-004, AVP2-006, AVP2-008, AVP2-010, AVP2-012, AVP2-014, AVP2-016 (2007), 16 descendants of its own

Source page: https://510kreport.com/device/K940189
Methodology: https://510kreport.com/methodology