K942024 is an FDA 510(k) clearance for the PORT-A-CATH LOW PROFILE IMPLANTABLE VENOUS ACCESS SYSTEM. This device is classified as a Port & Catheter, Implanted, Subcutaneous, Intravascular (Class II - Special Controls, product code LJT).
Submitted by Pharmacia Deltec, Inc. (St. Paul, US). The FDA issued a Cleared decision on July 26, 1994, 91 days after receiving the submission on April 26, 1994.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5965.
| 510(k) Number | K942024 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 26, 1994 |
| Decision Date | July 26, 1994 |
| Days to Decision | 91 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | LJT — Port & Catheter, Implanted, Subcutaneous, Intravascular |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5965 |