K101017 is an FDA 510(k) clearance for the ANGIODYNAMICS, INC., SMART PORT CT SERIES PORT ACCESS SYSTEMS. This device is classified as a Port & Catheter, Implanted, Subcutaneous, Intravascular (Class II - Special Controls, product code LJT).
Submitted by AngioDynamics, Inc. (Queensburgy, US). The FDA issued a Cleared decision on June 17, 2010, 66 days after receiving the submission on April 12, 2010.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5965.
| 510(k) Number | K101017 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 12, 2010 |
| Decision Date | June 17, 2010 |
| Days to Decision | 66 days |
| Submission Type | Special |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | LJT — Port & Catheter, Implanted, Subcutaneous, Intravascular |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5965 |