K040446 is an FDA 510(k) clearance for the ANGIODYNAMICS, INC. MORPHEUS PICC AND PROCEDURE KIT. This device is classified as a Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days (Class II - Special Controls, product code LJS).
Submitted by AngioDynamics, Inc. (Queensburgy, US). The FDA issued a Cleared decision on March 5, 2004, 14 days after receiving the submission on February 20, 2004.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5970.
| 510(k) Number | K040446 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 20, 2004 |
| Decision Date | March 05, 2004 |
| Days to Decision | 14 days |
| Submission Type | Special |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | LJS — Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5970 |