# K093406: Morpheus Smart Picc CT and Procedure Kit Model 12105509, 12105519 - Pathway: 510(k) (Special) - Applicant: AngioDynamics, Inc. - Decided: Mar 25, 2010 after 143 days - Product code: LJS (Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days) - Device class: 2 - Regulation: 21 CFR 880.5970 - Recalls of this device: 38 (0 Class I) - Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026 ## Lineage Longest line of descent: 7 generations back to K001901 (2000). 15 ancestors in all. No later device cites it as a predicate yet. 0 of 16 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K070615: Angiodynamics, Inc., Morpheus CT Picc and Procedure Kit, AngioDynamics, Inc. (2007) Summary page 1. - K060887: Angiodynamic, Inc. Morpheus CT Picc and Procedure Kit, AngioDynamics, Inc. (2006) Summary page 1. - K041420: Angiodynamics, Inc. Morpheus Picc and Procedure Kit, AngioDynamics, Inc. (2004) Summary page 5. - K040446: Angiodynamics, Inc. Morpheus Picc and Procedure Kit, AngioDynamics, Inc. (2004) Summary page 1. - K031626: Angiodynamics, Inc. Morpheus Picc and Procedure Kit, AngioDynamics, Inc. (2003) Summary page 1. - K030415: Angiodynamics, Inc. Morpheus Picc and Procedure Kit, AngioDynamics, Inc. (2003) Summary page 1. - K053501: Powerpicc, Bard Access Systems, Inc. (2006) Summary page 1. ## Recalls of this device - Feb 6, 2012 · Not classified · Z-1068-2012: The Morpheus Smart PICC label states the kit contains a Nitinol guidewire; however the kit contains a Platinum guidewire. - Feb 6, 2012 · Not classified · Z-1069-2012: The Morpheus Smart PICC label states the kit contains a Nitinol guidewire; however the kit contains a Platinum guidewire. - Jan 9, 2012 · Not classified · Z-0884-2012: The red luer on the Morpheus CT PICC (Peripherally Inserted Central Catheter) has the potential to crack during use of the product. - Jan 9, 2012 · Not classified · Z-0887-2012: The red luer on the Morpheus CT PICC (Peripherally Inserted Central Catheter) has the potential to crack during use of the product. - Jan 9, 2012 · Not classified · Z-0883-2012: The red luer on the Morpheus CT PICC (Peripherally Inserted Central Catheter) has the potential to crack during use of the product. - Jan 9, 2012 · Not classified · Z-0878-2012: The red luer on the Morpheus CT PICC (Peripherally Inserted Central Catheter) has the potential to crack during use of the product. - Jan 9, 2012 · Not classified · Z-0879-2012: The red luer on the Morpheus CT PICC (Peripherally Inserted Central Catheter) has the potential to crack during use of the product. - Jan 9, 2012 · Not classified · Z-0880-2012: The red luer on the Morpheus CT PICC (Peripherally Inserted Central Catheter) has the potential to crack during use of the product. - Jan 9, 2012 · Not classified · Z-0888-2012: The red luer on the Morpheus CT PICC (Peripherally Inserted Central Catheter) has the potential to crack during use of the product. - Jan 9, 2012 · Not classified · Z-0889-2012: The red luer on the Morpheus CT PICC (Peripherally Inserted Central Catheter) has the potential to crack during use of the product. - Jan 9, 2012 · Not classified · Z-0890-2012: The red luer on the Morpheus CT PICC (Peripherally Inserted Central Catheter) has the potential to crack during use of the product. - Jan 9, 2012 · Not classified · Z-0893-2012: The red luer on the Morpheus CT PICC (Peripherally Inserted Central Catheter) has the potential to crack during use of the product. - Jan 9, 2012 · Not classified · Z-0894-2012: The red luer on the Morpheus CT PICC (Peripherally Inserted Central Catheter) has the potential to crack during use of the product. - Jan 9, 2012 · Not classified · Z-0895-2012: The red luer on the Morpheus CT PICC (Peripherally Inserted Central Catheter) has the potential to crack during use of the product. - Jan 9, 2012 · Not classified · Z-0897-2012: The red luer on the Morpheus CT PICC (Peripherally Inserted Central Catheter) has the potential to crack during use of the product. - Jan 9, 2012 · Not classified · Z-0900-2012: The red luer on the Morpheus CT PICC (Peripherally Inserted Central Catheter) has the potential to crack during use of the product. - Jan 9, 2012 · Not classified · Z-0902-2012: The red luer on the Morpheus CT PICC (Peripherally Inserted Central Catheter) has the potential to crack during use of the product. - Jan 9, 2012 · Not classified · Z-0904-2012: The red luer on the Morpheus CT PICC (Peripherally Inserted Central Catheter) has the potential to crack during use of the product. - Jan 9, 2012 · Not classified · Z-0908-2012: The red luer on the Morpheus CT PICC (Peripherally Inserted Central Catheter) has the potential to crack during use of the product. - Jan 9, 2012 · Not classified · Z-0877-2012: The red luer on the Morpheus CT PICC (Peripherally Inserted Central Catheter) has the potential to crack during use of the product. - Jan 9, 2012 · Not classified · Z-0881-2012: The red luer on the Morpheus CT PICC (Peripherally Inserted Central Catheter) has the potential to crack during use of the product. - Jan 9, 2012 · Not classified · Z-0882-2012: The red luer on the Morpheus CT PICC (Peripherally Inserted Central Catheter) has the potential to crack during use of the product. - Jan 9, 2012 · Not classified · Z-0885-2012: The red luer on the Morpheus CT PICC (Peripherally Inserted Central Catheter) has the potential to crack during use of the product. - Jan 9, 2012 · Not classified · Z-0886-2012: The red luer on the Morpheus CT PICC (Peripherally Inserted Central Catheter) has the potential to crack during use of the product. - Jan 9, 2012 · Not classified · Z-0891-2012: The red luer on the Morpheus CT PICC (Peripherally Inserted Central Catheter) has the potential to crack during use of the product. - Jan 9, 2012 · Not classified · Z-0892-2012: The red luer on the Morpheus CT PICC (Peripherally Inserted Central Catheter) has the potential to crack during use of the product. - Jan 9, 2012 · Not classified · Z-0896-2012: The red luer on the Morpheus CT PICC (Peripherally Inserted Central Catheter) has the potential to crack during use of the product. - Jan 9, 2012 · Not classified · Z-0898-2012: The red luer on the Morpheus CT PICC (Peripherally Inserted Central Catheter) has the potential to crack during use of the product. - Jan 9, 2012 · Not classified · Z-0899-2012: The red luer on the Morpheus CT PICC (Peripherally Inserted Central Catheter) has the potential to crack during use of the product. - Jan 9, 2012 · Not classified · Z-0901-2012: The red luer on the Morpheus CT PICC (Peripherally Inserted Central Catheter) has the potential to crack during use of the product. - Jan 9, 2012 · Not classified · Z-0903-2012: The red luer on the Morpheus CT PICC (Peripherally Inserted Central Catheter) has the potential to crack during use of the product. - Jan 9, 2012 · Not classified · Z-0905-2012: The red luer on the Morpheus CT PICC (Peripherally Inserted Central Catheter) has the potential to crack during use of the product. - Jan 9, 2012 · Not classified · Z-0906-2012: The red luer on the Morpheus CT PICC (Peripherally Inserted Central Catheter) has the potential to crack during use of the product. - Jan 9, 2012 · Not classified · Z-0910-2012: The red luer on the Morpheus CT PICC (Peripherally Inserted Central Catheter) has the potential to crack during use of the product. - Jan 9, 2012 · Not classified · Z-0912-2012: The red luer on the Morpheus CT PICC (Peripherally Inserted Central Catheter) has the potential to crack during use of the product. - Jan 9, 2012 · Not classified · Z-0907-2012: The red luer on the Morpheus CT PICC (Peripherally Inserted Central Catheter) has the potential to crack during use of the product. - Jan 9, 2012 · Not classified · Z-0909-2012: The red luer on the Morpheus CT PICC (Peripherally Inserted Central Catheter) has the potential to crack during use of the product. - Jan 9, 2012 · Not classified · Z-0911-2012: The red luer on the Morpheus CT PICC (Peripherally Inserted Central Catheter) has the potential to crack during use of the product. ## Indications for use The AngioDynamics, Inc. Morpheus® SMART PICC CT and Procedure Kit is indicated for short or long term peripheral access to the central venous system for intravenous therapy, power injections of contrast media, and allows for central venous pressure monitoring. For blood sampling, infusion, or therapy use a 4 French or larger catheter. For central venous pressure monitoring, it is recommended that catheter lumen of 20 gauge or larger be used. Source page: https://510kreport.com/device/K093406 Methodology: https://510kreport.com/methodology