K060887 is an FDA 510(k) clearance for the ANGIODYNAMIC, INC. MORPHEUS CT 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 April 28, 2006, 28 days after receiving the submission on March 31, 2006.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5970.
| 510(k) Number | K060887 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 31, 2006 |
| Decision Date | April 28, 2006 |
| Days to Decision | 28 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 |