K240119 is an FDA 510(k) clearance 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 Cleared decision on February 16, 2024, 31 days after receiving the submission on January 16, 2024.
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 | K240119 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 16, 2024 |
| Decision Date | February 16, 2024 |
| Days to Decision | 31 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| 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. |