K070613 is an FDA 510(k) clearance for the ANGIODYNAMICS, 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 June 29, 2007, 116 days after receiving the submission on March 5, 2007.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5970.
| 510(k) Number | K070613 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 05, 2007 |
| Decision Date | June 29, 2007 |
| Days to Decision | 116 days |
| Submission Type | Traditional |
| 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 |