The Rinspirator, Models FG09770, FG08776, FG08777, FG08910
FDA 510(k) K071826 · Fox Hollow Technologies
510(k) numberK071826
Submission
- Device name
- The Rinspirator, Models FG09770, FG08776, FG08777, FG08910
- Applicant
- Fox Hollow Technologies
Redwood City, CA, US - Received
- July 3, 2007
- Decision date
- November 9, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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
| 510(k) | Device | Decision |
|---|---|---|
| K071432 | Silverhawk-R Peripheral Plaque Excision System for Surgical UseMCW · Traditional | 02/12/2008SE |
| K053460 | Modification to Silverhawk Peripheral Plaque Excision System, Models 02550, 04800…MCW · Special | 01/13/2006SE |
| K043553 | Silverhawk Peripheral Plaque Excision System, Models 02550,04800, 05200, 02406, 04706…MCW · Special | 02/18/2005SE |
| K024243 | Reform Peripheral Catheter System, Model 02200; Reform Peripheral Cathetercatheter…MCW · Traditional | 06/20/2003SE |
Questions and answers
When was The Rinspirator, Models FG09770, FG08776, FG08777, FG08910 cleared by the FDA?
The Rinspirator, Models FG09770, FG08776, FG08777, FG08910 (K071826) received a 510(k) decision of Substantially Equivalent on November 9, 2007, 129 days after the submission was received.
What is the product code of K071826?
The FDA product code is QEZ – Aspiration Thrombectomy Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.5150.