Merci Retriever, Models 90065, 90066
510(k) K033736
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK033736 | Date11 Aug 2004 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- NRY
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.1250
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 27 Sep 2026
The Merci Retriever is a thrombus retrieval device intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke. It is designed for use in patients who are ineligible for treatment with intravenous tissue plasminogen activator (IV t-PA). The device is classified as a Catheter, Thrombus Retriever in the cardiovascular medical specialty.
The Merci Retriever is supplied as a single-use device and requires appropriate storage conditions. It is available in multiple models including 90065 and 90066, with various sizes and configurations. The device received FDA 510(k) clearance with K033736 on August 11, 2004, and is regulated under product code NRY with regulation number 870.1250.
Other devices from Concentric Medical, Inc.
Questions
AI-generated answers, 27 Sep 2026
What is the Merci Retriever used for?
The Merci Retriever is a thrombus retrieval device designed to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke who are ineligible for treatment with intravenous tissue plasminogen activator (IV t-PA).
How is the Merci Retriever supplied and is it single-use?
The Merci Retriever is supplied as a single-use device and requires appropriate storage conditions. It is available in multiple models including 90065 and 90066, with various sizes and configurations to accommodate different clinical needs.
What regulatory status does the Merci Retriever have?
The Merci Retriever received FDA 510(k) clearance with K033736 on August 11, 2004, and is regulated under product code NRY with regulation number 870.1250. It is classified as a Class II device in the cardiovascular medical specialty.
What are the different models of the Merci Retriever available?
The Merci Retriever is available in multiple models including 90065 and 90066, with various sizes and configurations. These different models are designed to accommodate different anatomical considerations and clinical requirements during thrombus retrieval procedures.