Chemo-Port
510(k) K913386
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESK | NumberK913386 | Date10 Jan 1992 | StatusActive |
Official records
- FDA 510(k) database K913386
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- FMI
- Device class
- Class II
- Regulation
- 21 CFR Part 880.5570
- Advisory committee
- General Hospital
- FDA decision
- SESK Substantially Equivalent — Kit
Overview
AI-generated summary, 22 Sep 2026
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.
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