# K033736: Merci Retriever, Models 90065, 90066

- Pathway: 510(k) (Traditional)
- Applicant: Concentric Medical, Inc.
- Decided: Aug 11, 2004 after 257 days
- Product code: NRY (Catheter, Thrombus Retriever)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K003410 (2001). 2 ancestors in all.
159 later devices descend from it; 2 cite it directly.
8 of 162 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030476: Modified Concentric Retriever, Model 90037, Concentric Medical, Inc. (2003) Summary page 1.

## Most influential descendants
- K072718: Penumbra System (2007), 120 descendants of its own
- K100769: Penumbra System Separator Flex (026,032,041,054), Models PSF026, PSF032, PSF041, PSF054 (2010), 118 descendants of its own
- K113163: Penumbra System Max (2011), 116 descendants of its own
- K133317: Penumbra System / Penumbra System Max (2014), 61 descendants of its own
- K142458: Penumbra System ACE (2015), 60 descendants of its own

## Indications for use
The Merci Retriever is intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke. Patients who are ineligible for treatment with intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment. The Merci Retriever is also indicated for use in the retrieval of foreign bodies misplaced during interventional radiological procedures in the neuro, peripheral and coronary vasculature.

Source page: https://510kreport.com/device/K033736
Methodology: https://510kreport.com/methodology