K031626 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 June 19, 2003, 23 days after receiving the submission on May 27, 2003.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5970.
| 510(k) Number | K031626 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 27, 2003 |
| Decision Date | June 19, 2003 |
| Days to Decision | 23 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 |