Rinspiration Catheter System, Models 50135, 550135, P7065, P70135
FDA 510(k) K062275 · Kerberos Proximal Solutions, Inc.
510(k) numberK062275
Submission
- Device name
- Rinspiration Catheter System, Models 50135, 550135, P7065, P70135
- Applicant
- Kerberos Proximal Solutions, Inc.
Cupertino, CA, US - Received
- August 7, 2006
- Decision date
- September 20, 2006
- Decision
- Unknown (SESU)
- 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 |
|---|---|---|
| K050130 | Kerberos Proximal Solutions Rispiration SystemQEZ · Traditional | 05/13/2005SESU |
| K041123 | Rinspiration System,Rinspiration System Short Tip, Models FG01477/FG01703DQO · Traditional | 08/26/2004SESU |
| K041151 | Kerberos Occluding Guide Catheter and AccessoriesDQY · Traditional | 07/22/2004SE |
| K041291 | Rinspiration SystemDQO · Special | 05/21/2004SE |
| K031485 | Rinspiration SystemDQO · Traditional | 09/25/2003SE |
Questions and answers
When was Rinspiration Catheter System, Models 50135, 550135, P7065, P70135 cleared by the FDA?
Rinspiration Catheter System, Models 50135, 550135, P7065, P70135 (K062275) received a 510(k) decision of Unknown on September 20, 2006, 44 days after the submission was received.
What is the product code of K062275?
The FDA product code is QEZ – Aspiration Thrombectomy Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.5150.