K924250 is an FDA 510(k) clearance for the PLASTIC LOW PROFILE SUBCUTANEOUS PORT. This device is classified as a Port & Catheter, Implanted, Subcutaneous, Intravascular (Class II - Special Controls, product code LJT).
Submitted by Bard Access Systems, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on October 4, 1993, 406 days after receiving the submission on August 24, 1992.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5965.
| 510(k) Number | K924250 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 24, 1992 |
| Decision Date | October 04, 1993 |
| Days to Decision | 406 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 |