The following data is part of a premarket notification filed by Angiodynamics, Inc. with the FDA for Morpheus Smart Picc Ct And Procedure Kit Model 12105509, 12105519.
| Device ID | K093406 |
| 510k Number | K093406 |
| Device Name: | MORPHEUS SMART PICC CT AND PROCEDURE KIT MODEL 12105509, 12105519 |
| Classification | Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days |
| Applicant | ANGIODYNAMICS, INC. 603 QUEENSBURY AVE. Queensbury, NY 12804 |
| Contact | Jodi Lynn Frasier |
| Correspondent | Jodi Lynn Frasier ANGIODYNAMICS, INC. 603 QUEENSBURY AVE. Queensbury, NY 12804 |
| Product Code | LJS |
| CFR Regulation Number | 880.5970 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-11-02 |
| Decision Date | 2010-03-25 |
| Summary: | summary |