Modified Trevo Provue Retriever
FDA 510(k) K132641 · Concentric Medical, Inc.
510(k) numberK132641
Submission
- Device name
- Modified Trevo Provue Retriever
- Applicant
- Concentric Medical, Inc.
Mountain View, CA, US - Received
- August 26, 2013
- Decision date
- January 13, 2014
- 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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More from Rapid Medical Ltd.
| 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 |
| 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 |
| K122478 | Modified Trevo RetrieverNRY · Traditional | 10/31/2012SE |
Questions and answers
When was Modified Trevo Provue Retriever cleared by the FDA?
Modified Trevo Provue Retriever (K132641) received a 510(k) decision of Substantially Equivalent on January 13, 2014, 140 days after the submission was received.
What is the product code of K132641?
The FDA product code is NRY – Catheter, Thrombus Retriever, a Class II (moderate risk) device regulated under 21 CFR 870.1250.