Identifiers
- 510(k) Number
- K120917 FDA 510(k)
- FDA Product Code
- DQO FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.1200 FDA 510(k)
- Regulation Number
- 870.1200 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Headway Duo Microcatheter is a highly advanced, substanitally equivalent medical device designed for minimally invasive cardiovascular procedures. With its cutting-edge technology and streamlined design, it offers enhanced performance, increased patient safety, and improved outcomes.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K120917 | Class II | Active |
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Manufacturer
- Manufacturer
- Microvention Inc.
- FDA Applicant
- MicroVention, Inc.
Sources (1)
- FDA 510(k) K120917 24 fields · synced Jul 1, 2026