K955587 is an FDA 510(k) clearance for the VASCULAR ACCESS PORT KIT. This device is classified as a Port & Catheter, Implanted, Subcutaneous, Intravascular (Class II - Special Controls, product code LJT).
Submitted by Boston Scientific Corp (Natick,, US). The FDA issued a Cleared decision on March 21, 1996, 105 days after receiving the submission on December 7, 1995.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5965.
| 510(k) Number | K955587 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 07, 1995 |
| Decision Date | March 21, 1996 |
| Days to Decision | 105 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 |