K032600 is an FDA 510(k) clearance for the VAXCEL PORT, MODEL 45-333 AND VAXCEL W/PASV PORT, MODEL 45-233. This device is classified as a Port & Catheter, Implanted, Subcutaneous, Intravascular (Class II - Special Controls, product code LJT).
Submitted by Boston Scientific Corp (Glens Falls, US). The FDA issued a Cleared decision on September 9, 2003, 15 days after receiving the submission on August 25, 2003.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5965.
| 510(k) Number | K032600 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 25, 2003 |
| Decision Date | September 09, 2003 |
| Days to Decision | 15 days |
| Submission Type | Special |
| 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 |