K870260 is an FDA 510(k) clearance for the HICKMAN TITANIUM SUBCUTANEOUS PORT. This device is classified as a Port & Catheter, Implanted, Subcutaneous, Intravascular (Class II - Special Controls, product code LJT).
Submitted by C.R. Bard, Inc. (Murray Hill, US). The FDA issued a Cleared decision on April 15, 1987, 82 days after receiving the submission on January 23, 1987.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5965.
| 510(k) Number | K870260 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 23, 1987 |
| Decision Date | April 15, 1987 |
| Days to Decision | 82 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
| Product Code | LJT — Port & Catheter, Implanted, Subcutaneous, Intravascular |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5965 |