Identifiers
- 510(k) Number
- K241611 FDA 510(k)
- FDA Product Code
- DQY FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.1250 FDA 510(k)
- Regulation Number
- 870.1250 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The ShapeIT (SI014135) is a venous stent, a Class II cardiovascular device designed for use in venous interventions. It is intended to provide structural support and maintain patency in venous vessels, aiding in the treatment of venous occlusive diseases or post-intervention complications.
This device is supplied as a single-use, sterile product and is regulated under FDA 510(k) clearance (K241611) through the Traditional pathway. It is classified under product code DQY and manufactured by IMDS Operations B.V., located in Roden, Netherlands. No additional regulatory status beyond the stated FDA clearance is implied.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: K241611 - ShapeIT (SI014135) | FDA 510(k) | Imds Operations B.V., shapeit si014135 - Imds Operations | FDA Evidence Review, Imds Operations B.V. FDA 510 (k) Products - Latest 2025, PDF September 3, 2024 - accessdata.fda.gov
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K241611 | Class II | Active |
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Manufacturer
- Manufacturer
- IMDS Operations B.V.
Sources (1)
- FDA 510(k) K241611 24 fields · synced Sep 20, 2026