Triever16 Curve
510(k) K223419
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK223419 | Date23 Mar 2023 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- QEW
- Device class
- Class II
- Regulation
- 21 CFR Part 870.5150
- Advisory committee
- Cardiovascular
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Triever16 Curve Embolectomy Catheter is a peripheral mechanical thrombectomy device with aspiration capability. It is designed for the non-surgical removal of emboli and thrombi from blood vessels, as well as for the injection, infusion, and aspiration of contrast media and fluids. This device falls under the classification of a peripheral vascular thrombectomy system, enabling targeted intervention in occluded vessels.
The device is supplied as a single-use, reusable catheter in a 16 French (Fr) size with a .035-inch guidewire compatibility and a length of 110 cm. It is intended for use in peripheral vasculature and pulmonary embolism procedures. The Triever16 Curve has received FDA 510(k) clearance under the Special 510(k) pathway, with a classification of Class II medical device (QEW). Sterility and regulatory compliance are ensured through FDA-authorized manufacturing processes.