K873735 is an FDA 510(k) clearance for the MEDTRONIC CATHETER ACCESS PORT MODEL 8500. This device is classified as a Port & Catheter, Implanted, Subcutaneous, Intravascular (Class II - Special Controls, product code LJT).
Submitted by Medtronic Vascular (Minneapolis, US). The FDA issued a Cleared decision on November 3, 1987, 49 days after receiving the submission on September 15, 1987.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5965.
| 510(k) Number | K873735 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 15, 1987 |
| Decision Date | November 03, 1987 |
| Days to Decision | 49 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 |