# K043371: Biomerix Vascular Occlusion Device and Loader

- Pathway: 510(k) (Traditional)
- Applicant: Biomerix Corporation
- Decided: Feb 3, 2005 after 57 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
Longest line of descent: 6 generations back to K891688 (1989). 15 ancestors in all.
20 later devices descend from it; 2 cite it directly.
0 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031810: Amplatzer Vascular Plug, Aga Medical Corp. (2003) Summary page 1.

## Cited in the summary but kept off the family tree
- K942189: Crystal Ear, Crystal Care Intl., Inc. (1994). Our reading of the summary gave K942189, FDA’s number for Crystal Ear (Crystal Care Intl., Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Cook Embolization Coils”. Kept off the family tree. Summary page 1.

## Most influential descendants
- K070961: Biomerix Surgical Mesh, Model: RCR-01 (2008), 17 descendants of its own
- K072370: Surgicraft Surgical Mesh System (2008), 11 descendants of its own
- K090288: Orthadapt PR (2009), 7 descendants of its own
- K112786: Proseries Bioimplants-Proankle/Procuff (2011), 5 descendants of its own
- K220091: Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device (2022), 4 descendants of its own

## Indications for use
The Biomerix Vascular Occlusion Device is intended for arterial and venous embolization in the peripheral vasculature.

Source page: https://510kreport.com/device/K043371
Methodology: https://510kreport.com/methodology