Identifiers
- 510(k) Number
- K140910 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 CENTERCROSS CATHETER is a reliable and innovative medical device designed for minimally invasive catheterization procedures. It features advanced navigation systems, high-resolution imaging, and precise control, providing accurate measurements and data collection for comprehensive patient care.
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 | K140910 | Class II | Active |
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Manufacturer
- Manufacturer
- Roxwood Medical, Inc.
Sources (1)
- FDA 510(k) K140910 24 fields · synced Jun 25, 2026