← Back to catalogue
Vaccess CT Low-Profile Power-Injectable Implantable Port - Vaccess™ CT Power-Injectable Implantable Port
FDA 510(k)Class II (US FDA 510(k))
510(k) K252478
Identifiers
- 510(k) Number
- K252478 FDA 510(k)
- FDA Product Code
- LJT FDA 510(k)
- Models / Variants
- Vaccess™ CT Power-Injectable Implantable Port FDA 510(k)PowerPort™ duo M.R.I. ™ Implantable Port FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 880.5965 FDA 510(k)
- Regulation Number
- 880.5965 FDA 510(k)
- Advisory Committee
- General Hospital FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Vaccess CT Low-Profile Power-Injectable Implantable Port - Vaccess™ CT Power-Injectable Implantable Port by Bard Access Systems, Inc. — Class II — FDA_510K…
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 | K252478 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Bard Access Systems, Inc.
Sources (1)
- FDA 510(k) K252478 24 fields · synced Jun 18, 2026