Concentric Medical, Inc.
Medical device manufacturer in Mountain View, CA.
45510(k) clearances
0PMA approvals
6recalls
Device types
510(k) clearances
| 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 |
| K122478 | Modified Trevo RetrieverNRY · Traditional | 10/31/2012SE |
| K120961 | Trevo RetrieverNRY · Traditional | 08/03/2012SE |
| K112404 | Concentric Balloon Guide CatheterDQY · Traditional | 03/15/2012SE |
| K113260 | Modified Concentirc MicrocatheterDQO · Special | 03/09/2012SE |
| K111619 | Modified Concentric MicrocatheterDQO · Special | 07/06/2011SE |
| K110483 | Modified HD Guide CatheterDQY · Special | 04/04/2011SE |
| K093610 | Modified Retriever (Modified, Line Extension), Models 90152, 90153NRY · Traditional | 02/17/2011SE |
| K102657 | Concentric Balloon Guide CatheterDQY · Traditional | 11/17/2010SE |
| K092298 | Modification to Modified HD Guide CatheterDQY · Special | 11/05/2009SE |
| K091703 | HD Guide Catheter, Model 90019, 90022, 90023, 90120, 90121, 90130, 90131QEZ · Traditional | 10/14/2009SE |
| K091961 | Modified Concentric Microcatheter, Model 90047DQO · Special | 07/30/2009SE |
| K090335 | HD Guide CatheterDQY · Special | 05/06/2009SE |
| K090085 | Merci Retriever, Models 90050, 90060, 90066, 90070, 90110, 90111, 90112, 90113NRY · Special | 02/12/2009SE |
| K082034 | Modification to Merci RetrieverNRY · Special | 08/15/2008SE |
| K080583 | Modified HD Guide CatheterDQY · Special | 07/18/2008SE |
| K081305 | Merci RetrieverNRY · Special | 06/05/2008SE |
| K072796 | Meerci Retriever, Concentric Microcatheter, Models 90050, 90060, 90065, 90066…DQO · Special | 12/18/2007SE |
| K071172 | Modified Merci Retriever, Model 90060NRY · Traditional | 08/22/2007SE |
| K070521 | Modified Mercy Retriever, Model 90070NRY · Special | 04/24/2007SE |
| K063774 | Modification to Merci Retriever, Models X5 and X6NRY · Special | 01/24/2007SE |
| K062046 | Modified Merci Retriever, Model 90050NRY · Traditional | 01/19/2007SE |
| K061059 | Modified Merci Retriever, Model 90092NRY · Special | 05/25/2006SE |
| K051838 | Modified Concentric Retriever, Model 90039DQY · Special | 09/01/2005SE |
| K050470 | Concentric Embolic PearlsKRD · Traditional | 05/06/2005SE |
| K040745 | Modified Concentric Retriever, Model 90038DQY · Traditional | 08/11/2004SE |
| K033736 | Merci Retriever, Models 90065, 90066NRY · Traditional | 08/11/2004SE |
| K040700 | Concentric Retriever X5, Model 90035; Concentric Retriever X6, Model 90037DQY · Special | 06/21/2004SE |
| K030476 | Modified Concentric Retriever, Model 90037DQY · Special | 03/11/2003SE |
| K021899 | Concentric Balloon Guide Catheter, Model 90072DQY · Special | 07/10/2002SE |
| K010954 | Concentric Balloon Guide Catheter, Model 90031DQY · Traditional | 10/09/2001SE |
| K003410 | Concentric Retriever, Model 90030DQY · Traditional | 05/22/2001SE |
| K003880 | Concentroc HD Guide Catheter, Models 90017 (4F), 90019 (5F), 90021 (6F), 90022 (7F)…DQY · Abbreviated | 05/16/2001SE |
| K003086 | Concentric Micro Catheter, Models 90001 to 90008DQO · Traditional | 05/16/2001SE |
| K003084 | Concentric Hydrophilic Guidewire, Models 90011, 90012DQX · Traditional | 05/16/2001SE |
| K003085 | Concentric Guide Catheter, Models 90018, 90020DQY · Traditional | 03/07/2001SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-0116-2016 Class II | Distal Access Catheters - 044 - 115 cm: Finished Good Number 90960-001 / REF 90960.…One Distal Access Catheter intended for distribution in Korea, was found at a US location. | 08/19/2015Terminated |
| Z-2598-2014 Class II | Merci Retriever Intended to restore blood flow in the neurovasculature by removing…Merci Retrievers were shipped to US customers past their expiration date, even though they were labeled with… | 06/25/2014Terminated |
| Z-0528-2015 Class II | Trevo Pro 4 Stent Retriever, Model number 80021; U.S. Indications for use: The Trevo…Product shipped to US customers had non U.S. Instruction for use with indication for Use that were not… | 11/13/2013Terminated |
| Z-0525-2015 Class II | Distal Access Catheter: Model Numbers: 90121, 90130, 90131, 90160. The Distal Access…Distal Access Catheters were shipped to US customers with the Directions for Use that included instructions… | 09/26/2013Terminated |
| Z-0655-2013 Class II | FlowGate Balloon Guide Catheter; Manufactured by Concentric Medical, Mountain View, CA.…Firm received complaints of resistance and possible collapse of the distal tip of the FlowGate Balloon Guide… | 12/20/2012Terminated |
| Z-0899-2011 | Concentric 7F Balloon Guide Catheter (percutaneous catheter per 21 CFR 870.1250), REF…Product malfunction-- hub may leak at connection to the shaft due to insufficient adhesive curing. | 02/27/2009Terminated |