K093406 is an FDA 510(k) clearance for the MORPHEUS SMART PICC CT AND PROCEDURE KIT MODEL 12105509, 12105519. 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 25, 2010, 143 days after receiving the submission on November 2, 2009.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5970.
| 510(k) Number | K093406 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 02, 2009 |
| Decision Date | March 25, 2010 |
| Days to Decision | 143 days |
| Submission Type | Special |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | LJS — Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5970 |