ClearanceBrief
510(k) K093406 ยท LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days

MORPHEUS SMART PICC CT AND PROCEDURE KIT MODEL 12105509, 12105519

ApplicantAngioDynamics, Inc., Queensburgy NY, US
DecisionSubstantially Equivalent, Mar 25, 2010
ReceivedNov 2, 2009
TypeSpecial
FDA recordOpen on fda.gov

Recalls that name K093406

DateFirm and productCodeLinked 510(k)
Feb 21, 2012Angiodynamics Worldwide Headquarters
AngioDynamics SPECIAL ORDER Morpheus Smart PICC CT --- 5F Dual Lumen 65cm --- Max CT Flow Rate: 4mL/sec --- Kit Contains: --- 1 each Nitinol Guidewire, 0.46mm (0.018in.) x 130cm --- Catalog No. [REF]
Terminated
LJSNone listed
Feb 21, 2012Angiodynamics Worldwide Headquarters
AngioDynamics SPECIAL ORDER Morpheus Smart PICC CT --- 4F Single Lumen 65cm --- Max CT Flow Rate: 4mL/sec --- Kit Contains: --- 1 each Nitinol Guidewire, 0.46mm (0.018in.) x 130cm --- Catalog No. [REF
Terminated
LJSNone listed
Jan 26, 2012Angiodynamics Worldwide Headquarters
AngioDynamics Morpheus Smart PICC CT 65cm 5F Dual Lumen --- Max CT Flow Rate: 4 mL/SEC --- Injector Pressure Limit: 300 PSI --- Catalog No. [REF] 12100805 --- Made in the USA --- [Manufacturing symbol
Terminated
LJSNone listed
Jan 26, 2012Angiodynamics Worldwide Headquarters
AngioDynamics Morpheus Smart PICC CT 65cm 5F Dual Lumen with REVERSE TAPER --- Max CT Flow Rate: 4mL/SEC --- Injector Pressure Limit: 300 PSI --- Catalog No. [REF] 12102604 --- Made in the USA --- [Ma
Terminated
LJSNone listed
Jan 26, 2012Angiodynamics Worldwide Headquarters
AngioDynamics Morpheus Smart PICC CT 65cm 5F Dual Lumen with REVERSE TAPER --- Max CT Flow Rate: 4mL/SEC --- Injector Pressure Limit: 300 PSI --- Catalog No. [REF] 12102605 --- Made in the USA --- [Ma
Terminated
LJSNone listed
Jan 26, 2012Angiodynamics Worldwide Headquarters
AngioDynamics Morpheus Smart PICC CT 65cm 6F Dual Lumen with REVERSE TAPER --- Max CT Flow Rate: 6mL/SEC --- Injector Pressure Limit: 300 PSI --- Catalog No. [REF] 12102606 --- Made in the USA --- [Ma
Terminated
LJSNone listed
Jan 26, 2012Angiodynamics Worldwide Headquarters
AngioDynamics Morpheus Smart PICC CT 65cm 5F Dual Lumen with REVERSE TAPER --- Max CT Flow Rate: 4mL/SEC --- Injector Pressure Limit: 300 PSI --- Catalog No. [REF] 12102611 --- Made in the USA --- [Ma
Terminated
LJSNone listed
Jan 26, 2012Angiodynamics Worldwide Headquarters
AngioDynamics Morpheus Smart PICC CT 65cm 6F Dual Lumen with REVERSE TAPER --- Max CT Flow Rate: 6mL/SEC --- Injector Pressure Limit: 300 PSI --- Catalog No. [REF] 12102613 --- Made in the USA --- [Ma
Terminated
LJSNone listed
Jan 26, 2012Angiodynamics Worldwide Headquarters
AngioDynamics Morpheus Smart PICC CT 55cm 5F Dual Lumen with REVERSE TAPER --- Max CT Flow Rate: 5mL/SEC --- Injector Pressure Limit: 300 PSI --- Catalog No. [REF] 12102616 --- Made in the USA --- [Ma
Terminated
LJSNone listed
Jan 26, 2012Angiodynamics Worldwide Headquarters
AngioDynamics Morpheus Smart PICC CT 55cm 6F Dual Lumen with REVERSE TAPER --- Max CT Flow Rate: 5mL/SEC --- Injector Pressure Limit: 300 PSI --- Catalog No. [REF] 12102617 --- Made in the USA --- [Ma
Terminated
LJSNone listed
Jan 26, 2012Angiodynamics Worldwide Headquarters
AngioDynamics Morpheus Smart PICC CT 65cm 5F Dual Lumen --- Max CT Flow Rate: 4mL/SEC --- Injector Pressure Limit: 300 PSI --- Catalog No. [REF] 12102805 --- Made in the USA --- [Manufacturing symbol]
Terminated
LJSNone listed
Jan 26, 2012Angiodynamics Worldwide Headquarters
AngioDynamics Morpheus Smart PICC CT 65cm 6F Dual Lumen --- Max CT Flow Rate: 6mL/SEC --- Injector Pressure Limit: 300 PSI --- Catalog No. [REF] 12102806 --- Made in the USA --- [Manufacturing symbol]
Terminated
LJSNone listed
Jan 26, 2012Angiodynamics Worldwide Headquarters
AngioDynamics Morpheus Smart PICC CT 65cm 5F Dual Lumen --- Max CT Flow Rate: 4mL/SEC --- Injector Pressure Limit: 300 PSI --- Catalog No. [REF] 12102812 --- Made in the USA --- [Manufacturing symbol]
Terminated
LJSNone listed
Jan 26, 2012Angiodynamics Worldwide Headquarters
AngioDynamics Morpheus Smart PICC CT 65cm 5F Dual Lumen --- Max CT Flow Rate: 4mL/SEC --- Injector Pressure Limit: 300 PSI --- Catalog No. [REF] 12102813 --- Made in the USA --- [Manufacturing symbol]
Terminated
LJSNone listed
Jan 26, 2012Angiodynamics Worldwide Headquarters
AngioDynamics Morpheus Smart PICC CT 65cm 5F Dual Lumen --- Max CT Flow Rate: 4mL/SEC --- Injector Pressure Limit: 300 PSI --- Catalog No. [REF] 12102821 --- Made in the USA --- [Manufacturing symbol]
Terminated
LJSNone listed
Jan 26, 2012Angiodynamics Worldwide Headquarters
AngioDynamics Morpheus Smart PICC CT 65cm 5F Dual Lumen --- Max CT Flow Rate: 4mL/SEC --- Injector Pressure Limit: 300 PSI --- Catalog No. [REF] 12102829 --- Made in the USA --- [Manufacturing symbol]
Terminated
LJSNone listed
Jan 26, 2012Angiodynamics Worldwide Headquarters
AngioDynamics Morpheus Smart PICC CT 65cm 5F Dual Lumen with REVERSE TAPER --- Max CT Flow Rate: 4mL/SEC --- Injector Pressure Limit: 300 PSI --- Catalog No. [REF] 12104605 --- Made in the USA --- [Ma
Terminated
LJSNone listed
Jan 26, 2012Angiodynamics Worldwide Headquarters
AngioDynamics Morpheus Smart PICC CT 65cm 6F Dual Lumen with REVERSE TAPER --- Max CT Flow Rate: 6mL/SEC --- Injector Pressure Limit: 300 PSI --- Catalog No. [REF] 12104606 --- Made in the USA --- [Ma
Terminated
LJSNone listed
Jan 26, 2012Angiodynamics Worldwide Headquarters
AngioDynamics Morpheus Smart PICC CT 65cm 5F Dual Lumen with REVERSE TAPER --- Max CT Flow Rate: 4mL/SEC --- Injector Pressure Limit: 300 PSI --- Catalog No. [REF] 12104612 --- Made in the USA --- [Ma
Terminated
LJSNone listed
Jan 26, 2012Angiodynamics Worldwide Headquarters
AngioDynamics Morpheus Smart PICC CT 65cm 5F Dual Lumen --- Max CT Flow Rate: 4mL/SEC --- Injector Pressure Limit: 300 PSI --- Catalog No. [REF] 12104805 --- Made in the USA --- [Manufacturing symbol]
Terminated
LJSNone listed
Jan 26, 2012Angiodynamics Worldwide Headquarters
AngioDynamics Morpheus Smart PICC CT 65cm 5F Dual Lumen --- Max CT Flow Rate: 4mL/SEC --- Injector Pressure Limit: 300 PSI --- Catalog No. [REF] 12104813 --- Made in the USA --- [Manufacturing symbol]
Terminated
LJSNone listed
Jan 26, 2012Angiodynamics Worldwide Headquarters
AngioDynamics Morpheus Smart PICC CT 65cm 6F Dual Lumen --- Max CT Flow Rate: 6mL/SEC --- Injector Pressure Limit: 300 PSI --- Catalog No. [REF] 12104814 --- Made in the USA --- [Manufacturing symbol]
Terminated
LJSNone listed
Jan 26, 2012Angiodynamics Worldwide Headquarters
AngioDynamics Morpheus Smart PICC CT 65cm 5F Dual Lumen --- Max CT Flow Rate: 4mL/SEC --- Injector Pressure Limit: 300 PSI --- Catalog No. [REF] 12104821 --- Made in the USA --- [Manufacturing symbol]
Terminated
LJSNone listed
Jan 26, 2012Angiodynamics Worldwide Headquarters
AngioDynamics Morpheus Smart PICC CT 65cm 6F Dual Lumen --- Max CT Flow Rate: 6mL/SEC --- Injector Pressure Limit: 300 PSI --- Catalog No. [REF] 12104830 --- Made in the USA --- [Manufacturing symbol]
Terminated
LJSNone listed
Jan 26, 2012Angiodynamics Worldwide Headquarters
AngioDynamics Morpheus Smart PICC CT 5F Dual Lumen 65cm --- Max CT Flow Rate: 4mL/SEC --- Catalog No.: 12110904 --- AngioDynamics, Inc., 603 Queensbury Avenue, Queensbury, NY 12804 --- Assembled and P
Terminated
LJSNone listed
Jan 26, 2012Angiodynamics Worldwide Headquarters
AngioDynamics Morpheus Smart PICC CT 5F Dual Lumen w/ Reverse Taper 65cm --- Max CT Flow Rate: 4mL/sec --- Catalog No.: 12110917 --- AngioDynamics, Inc., 603 Queensbury Avenue, Queensbury, NY 12804 --
Terminated
LJSNone listed
Jan 26, 2012Angiodynamics Worldwide Headquarters
AngioDynamics Morpheus Smart PICC CT 6F Dual Lumen w/ Reverse Taper 65cm --- Max CT Flow Rate: 6mL/sec --- Catalog No.: 12110918 --- AngioDynamics, Inc., 603 Queensbury Avenue, Queensbury, NY 12804 --
Terminated
LJSNone listed
Jan 26, 2012Angiodynamics Worldwide Headquarters
AngioDynamics Morpheus Smart PICC CT 5F Dual Lumen w/ Reverse Taper 65cm --- Max CT Flow Rate: 4mL/sec --- Catalog No.: 12110919 --- AngioDynamics, Inc., 603 Queensbury Avenue, Queensbury, NY 12804 --
Terminated
LJSNone listed
Jan 26, 2012Angiodynamics Worldwide Headquarters
AngioDynamics Morpheus Smart PICC CT with Stylet 5F Dual Lumen 65cm --- Max CT Flow Rate: 4mL/sec --- Catalog No.: 12110923 --- AngioDynamics, Inc., 603 Queensbury Avenue, Queensbury, NY 12804 --- Ass
Terminated
LJSNone listed
Jan 26, 2012Angiodynamics Worldwide Headquarters
AngioDynamics Morpheus Smart PICC CT with Stylet 5F Dual Lumen w/ Reverse Taper 65cm --- Max CT Flow Rate: 4mL/sec --- Catalog No.: 12110929 --- AngioDynamics, Inc., 603 Queensbury Avenue, Queensbury,
Terminated
LJSNone listed
Jan 26, 2012Angiodynamics Worldwide Headquarters
AngioDynamics Morpheus Smart PICC CT 5F Dual Lumen w/ Reverse Taper 65cm --- Max CT Flow Rate: 4mL/sec --- Catalog No.: 12110934 --- AngioDynamics, Inc., 603 Queensbury Avenue, Queensbury, NY 12804 --
Terminated
LJSNone listed
Jan 26, 2012Angiodynamics Worldwide Headquarters
AngioDynamics Morpheus Smart PICC CT 5F Dual Lumen w/ Reverse Taper 55cm --- Max CT Flow Rate: 5mL/sec --- Catalog No.: 12110936 --- AngioDynamics, Inc., 603 Queensbury Avenue, Queensbury, NY 12804 --
Terminated
LJSNone listed
Jan 26, 2012Angiodynamics Worldwide Headquarters
AngioDynamics Morpheus Smart PICC CT with Stylet 5F Dual Lumen w/ Reverse Taper 55cm --- Max CT Flow Rate: 5mL/sec --- Catalog No.: 12110937 --- AngioDynamics, Inc., 603 Queensbury Avenue, Queensbury,
Terminated
LJSNone listed
Jan 26, 2012Angiodynamics Worldwide Headquarters
AngioDynamics Morpheus Smart PICC CT 6F Triple Lumen w/ Reverse Taper 55cm --- Max CT Flow Rate: 5mL/sec --- Catalog No.: 12110941 --- AngioDynamics, Inc., 603 Queensbury Avenue, Queensbury, NY 12804
Terminated
LJSNone listed
Jan 26, 2012Angiodynamics Worldwide Headquarters
AngioDynamics Special Order Morpheus Smart PICC CT 65cm 5F Dual Lumen with Reverse Taper --- Max CT Flow Rate: 4mL/sec --- Injector Pressure Limit --- Catalog No.: 52100602 --- Made in the USA --- [Ma
Terminated
LJSNone listed
Jan 26, 2012Angiodynamics Worldwide Headquarters
AngioDynamics Special Order Morpheus Smart PICC CT 65cm 5F Dual Lumen with Reverse Taper --- Max CT Flow Rate: 4mL/sec --- Injector Pressure Limit --- Catalog No.: 52102618 --- Made in the USA --- [Ma
Terminated
LJSNone listed
Jan 26, 2012Angiodynamics Worldwide Headquarters
AngioDynamics Special Order Morpheus Smart PICC CT 65cm 6F Dual Lumen with Reverse Taper --- Max CT Flow Rate: 6mL/sec --- Injector Pressure Limit --- Catalog No.: 52102624 --- Made in the USA --- [Ma
Terminated
LJSNone listed
Jan 26, 2012Angiodynamics Worldwide Headquarters
AngioDynamics Special Order Morpheus Smart PICC CT 65cm 5F Dual Lumen with Reverse Taper --- Max CT Flow Rate: 4mL/sec --- Injector Pressure Limit --- Catalog No.: 52102638--- Made in the USA --- [Man
Terminated
LJSNone listed

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