Identifiers
- 510(k) Number
- K913386 FDA 510(k)
- FDA Product Code
- FMI FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 880.5570 FDA 510(k)
- Regulation Number
- 880.5570 FDA 510(k)
- Advisory Committee
- General Hospital FDA 510(k)
- FDA Decision
- SESK Substantially Equivalent — Kit FDA 510(k)
The Chemo-Port is a medical device designed for vascular access. It facilitates the delivery of therapeutic substances into the circulatory system.
This device is authorized under FDA 510(k) clearance K913386. It is manufactured by Hdc Corp. and is classified for use within general hospital settings.
Frequently asked questions
What is the primary function of the Chemo-Port?
The Chemo-Port is designed for vascular access, providing a reliable method for the delivery of therapeutic substances directly into a patient's circulatory system.
In what environment is the Chemo-Port intended to be used?
This device is classified for use within general hospital settings, where it supports the administration of necessary therapies to patients.
What is the regulatory status of this device?
The Chemo-Port is authorized under FDA 510(k) clearance, specifically identified by submission number K913386, which was granted on January 10, 1992.
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: K874184 - CHEMO-PORT | FDA 510 (k) | Hdc Corp., K853332 - HDC CHEMO-PORT (VASCULAR) | FDA 510 (k) | Hdc Corp., HDC CHEMO-PORT (VASCULAR) (K853332) — FDA 510(k) | Innolitics, CHEMO-PORT (K913386) — FDA 510(k) | Innolitics, HDC CHEMO-PORT (VASCULAR) 510(k) K853332 - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K913386 | Class II | Active |
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Manufacturer
- Manufacturer
- Hdc Corp.
Sources (1)
- FDA 510(k) K913386 24 fields · synced Sep 22, 2026