HD Guide Catheter, Model 90019, 90022, 90023, 90120, 90121, 90130, 90131
FDA 510(k) K091703 · Concentric Medical, Inc.
510(k) numberK091703
Submission
- Device name
- HD Guide Catheter, Model 90019, 90022, 90023, 90120, 90121, 90130, 90131
- Applicant
- Concentric Medical, Inc.
Mountain View, CA, US - Received
- June 10, 2009
- Decision date
- October 14, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QEZ – Aspiration Thrombectomy Catheter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.5150
- Specialty
- Cardiovascular
To remove thrombus from the peripheral and/or coronary vasculature through aspiration.
Other 510(k)s with product code QEZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K254035 | Mayumi Thrombectomy SystemQEZ · Traditional | MicroVention, Inc., d/b/a Terumo Neuro | 09/03/2026SE |
| K261105 | Powered Aventus Thrombectomy SystemQEZ · Traditional | Inquis Medical | 07/27/2026SE |
| K262030 | Aventus Thrombectomy SystemQEZ · Special | Inquis Medical | 07/15/2026SE |
| K253589 | Liberant RX Aspiration CatheterQEZ · Traditional | Medtronic Interventional Vascular, Inc. | 04/23/2026SE |
| K254208 | FLOWRUNNER Aspiration SystemQEZ · Special | Expanse Medical, Inc. | 03/20/2026SE |
| K253925 | Aventus Thrombectomy SystemQEZ · Traditional | Inquis Medical | 01/15/2026SE |
| K252509 | AlphaVac Multipurpose Mechanical Aspiration System F1885QEZ · Traditional | AngioDynamics, Inc. | 11/24/2025SE |
| K251312 | Vesalio Peripheral SystemQEZ · Traditional | Vesalio, Inc. | 10/24/2025SE |
| K251488 | FLOWRUNNER Aspiration SystemQEZ · Special | Expanse Medical, Inc. | 07/14/2025SE |
| K243549 | JETi Hydrodynamic Thrombectomy SystemQEZ · Traditional | Abbott Medical | 04/04/2025SE |
More from Abbott Medical
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|---|---|---|
| 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 HD Guide Catheter, Model 90019, 90022, 90023, 90120, 90121, 90130, 90131 cleared by the FDA?
HD Guide Catheter, Model 90019, 90022, 90023, 90120, 90121, 90130, 90131 (K091703) received a 510(k) decision of Substantially Equivalent on October 14, 2009, 126 days after the submission was received.
What is the product code of K091703?
The FDA product code is QEZ – Aspiration Thrombectomy Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.5150.