K832906 is an FDA 510(k) clearance for the PORT-A-CATH IMPLANTABLE CATHETER SYS. This device is classified as a Port & Catheter, Implanted, Subcutaneous, Intraperitoneal (Class II - Special Controls, product code LLD).
Submitted by Pharmacia, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 6, 1984, 190 days after receiving the submission on August 29, 1983.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5965.
| 510(k) Number | K832906 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 29, 1983 |
| Decision Date | March 06, 1984 |
| Days to Decision | 190 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
| Product Code | LLD — Port & Catheter, Implanted, Subcutaneous, Intraperitoneal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5965 |