DEN220026 is an FDA 510(k) submission for the VasQ. This device is classified as a Extravascular Support For An Arteriovenous Fistula For Vascular Access (Class II - Special Controls, product code QVQ).
Submitted by Laminate Medical Technologies , Ltd. (Tel Aviv, IL). The FDA issued a Not Cleared (DENG) decision on September 26, 2023.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4600. This Device Is A Permanent Implant Which Is Surgically Placed Outside And/or Around An Artery And/or Vein To Provide External Support To Arteriovenous Fistulas Created For Vascular Access By Means Of Vascular Surgery..
| 510(k) Number | DEN220026 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | April 29, 2022 |
| Decision Date | September 26, 2023 |
| Days to Decision | 515 days |
| Submission Type | Direct |
| Review Panel | Cardiovascular (CV) |
| Summary | - |
| Product Code | QVQ - Extravascular Support For An Arteriovenous Fistula For Vascular Access |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.4600 |
| Definition | This Device Is A Permanent Implant Which Is Surgically Placed Outside And/or Around An Artery And/or Vein To Provide External Support To Arteriovenous Fistulas Created For Vascular Access By Means Of Vascular Surgery. |