Merci Retriever, Models 90065, 90066
FDA 510(k) K033736 · Concentric Medical, Inc.
510(k) numberK033736
Submission
- Device name
- Merci Retriever, Models 90065, 90066
- Applicant
- Concentric Medical, Inc.
Mountain View, CA, US - Received
- November 28, 2003
- Decision date
- August 11, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NRY – Catheter, Thrombus Retriever
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1250
- Specialty
- Cardiovascular
The device is intended to restore blood flow by removing thrombus/clots in patients experiencing ischemic stroke. The prior clearances in this category have been limited to simply identifying catheter placed in the peripheral, coronary, and neurovasculature. It is felt that this is a unique claim and should not be combined with previously cleared catheters under a general procode.
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| 510(k) | Device | Decision |
|---|---|---|
| K173352 | Trevo Pro Vue Retriever and Trevo XP Pro Vue Retriever (Trevo Retriever)POL · Traditional | 02/15/2018SE |
| K153729 | 8F FlowGate2 Balloon Guide CatheterDQY · Special | 01/27/2016SE |
| K150616 | Trevo XP ProVue Retriever (4x30mm)NRY · Traditional | 06/12/2015SE |
| K143077 | Trevo XP ProVue Retriever (6X25mm)NRY · Traditional | 04/06/2015SE |
| K133177 | Modified HD Guide CatheterDQY · Traditional | 02/25/2014SE |
| K133464 | Modified Trevo Provue RetrieverNRY · Special | 01/17/2014SE |
| K132641 | Modified Trevo Provue RetrieverNRY · Traditional | 01/13/2014SE |
| K131437 | Modified Concentric MicrocatheterDQO · Traditional | 10/11/2013SE |
| K131492 | Modified Flowgate Balloon Guide CatheterDQY · Traditional | 10/03/2013SE |
| K122581 | Modified Balloon Guide Catheter Model 90253, 90254DQY · Traditional | 11/21/2012SE |
Questions and answers
When was Merci Retriever, Models 90065, 90066 cleared by the FDA?
Merci Retriever, Models 90065, 90066 (K033736) received a 510(k) decision of Substantially Equivalent on August 11, 2004, 257 days after the submission was received.
What is the product code of K033736?
The FDA product code is NRY – Catheter, Thrombus Retriever, a Class II (moderate risk) device regulated under 21 CFR 870.1250.