Atlas FDA

MORPHEUS SMART PICC CT AND PROCEDURE KIT MODEL 12105509, 12105519

FDA 510(k) clearance K093406 · decided 2010-03-25

Clearance details

K-number
K093406
Device name
MORPHEUS SMART PICC CT AND PROCEDURE KIT MODEL 12105509, 12105519
Applicant
AngioDynamics, Inc.
Decision
Substantially Equivalent
Date received
2009-11-02
Decision date
2010-03-25
Days to decision
143 days
Clearance type
Special
Product code
LJS
Device class
2
Regulation number
880.5970
Medical specialty
General Hospital
Advisory committee
General Hospital
Location
Queensburgy, NY, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
AngioDynamics SPECIAL ORDER Morpheus Smart PICC CT --- 5F Dual Lumen 65cm --- Max CT Flow recall (Z-1068-2012)Angiodynamics Worldwide Headquarters2012-02-21
AngioDynamics SPECIAL ORDER Morpheus Smart PICC CT --- 4F Single Lumen 65cm --- Max CT Flo recall (Z-1069-2012)Angiodynamics Worldwide Headquarters2012-02-21
AngioDynamics Morpheus Smart PICC CT 65cm 5F Dual Lumen --- Max CT Flow Rate: 4 mL/SEC --- recall (Z-0877-2012)Angiodynamics Worldwide Headquarters2012-01-26
AngioDynamics Morpheus Smart PICC CT 65cm 5F Dual Lumen with REVERSE TAPER --- Max CT Flow recall (Z-0878-2012)Angiodynamics Worldwide Headquarters2012-01-26
AngioDynamics Morpheus Smart PICC CT 65cm 5F Dual Lumen with REVERSE TAPER --- Max CT Flow recall (Z-0879-2012)Angiodynamics Worldwide Headquarters2012-01-26
AngioDynamics Morpheus Smart PICC CT 65cm 6F Dual Lumen with REVERSE TAPER --- Max CT Flow recall (Z-0880-2012)Angiodynamics Worldwide Headquarters2012-01-26
AngioDynamics Morpheus Smart PICC CT 65cm 5F Dual Lumen with REVERSE TAPER --- Max CT Flow recall (Z-0881-2012)Angiodynamics Worldwide Headquarters2012-01-26
AngioDynamics Morpheus Smart PICC CT 65cm 6F Dual Lumen with REVERSE TAPER --- Max CT Flow recall (Z-0882-2012)Angiodynamics Worldwide Headquarters2012-01-26
AngioDynamics Morpheus Smart PICC CT 55cm 5F Dual Lumen with REVERSE TAPER --- Max CT Flow recall (Z-0883-2012)Angiodynamics Worldwide Headquarters2012-01-26
AngioDynamics Morpheus Smart PICC CT 55cm 6F Dual Lumen with REVERSE TAPER --- Max CT Flow recall (Z-0884-2012)Angiodynamics Worldwide Headquarters2012-01-26
AngioDynamics Morpheus Smart PICC CT 65cm 5F Dual Lumen --- Max CT Flow Rate: 4mL/SEC --- recall (Z-0885-2012)Angiodynamics Worldwide Headquarters2012-01-26
AngioDynamics Morpheus Smart PICC CT 65cm 6F Dual Lumen --- Max CT Flow Rate: 6mL/SEC --- recall (Z-0886-2012)Angiodynamics Worldwide Headquarters2012-01-26
AngioDynamics Morpheus Smart PICC CT 65cm 5F Dual Lumen --- Max CT Flow Rate: 4mL/SEC --- recall (Z-0887-2012)Angiodynamics Worldwide Headquarters2012-01-26
AngioDynamics Morpheus Smart PICC CT 65cm 5F Dual Lumen --- Max CT Flow Rate: 4mL/SEC --- recall (Z-0888-2012)Angiodynamics Worldwide Headquarters2012-01-26
AngioDynamics Morpheus Smart PICC CT 65cm 5F Dual Lumen --- Max CT Flow Rate: 4mL/SEC --- recall (Z-0889-2012)Angiodynamics Worldwide Headquarters2012-01-26
AngioDynamics Morpheus Smart PICC CT 65cm 5F Dual Lumen --- Max CT Flow Rate: 4mL/SEC --- recall (Z-0890-2012)Angiodynamics Worldwide Headquarters2012-01-26
AngioDynamics Morpheus Smart PICC CT 65cm 5F Dual Lumen with REVERSE TAPER --- Max CT Flow recall (Z-0891-2012)Angiodynamics Worldwide Headquarters2012-01-26
AngioDynamics Morpheus Smart PICC CT 65cm 6F Dual Lumen with REVERSE TAPER --- Max CT Flow recall (Z-0892-2012)Angiodynamics Worldwide Headquarters2012-01-26
AngioDynamics Morpheus Smart PICC CT 65cm 5F Dual Lumen with REVERSE TAPER --- Max CT Flow recall (Z-0893-2012)Angiodynamics Worldwide Headquarters2012-01-26
AngioDynamics Morpheus Smart PICC CT 65cm 5F Dual Lumen --- Max CT Flow Rate: 4mL/SEC --- recall (Z-0894-2012)Angiodynamics Worldwide Headquarters2012-01-26
AngioDynamics Morpheus Smart PICC CT 65cm 5F Dual Lumen --- Max CT Flow Rate: 4mL/SEC --- recall (Z-0895-2012)Angiodynamics Worldwide Headquarters2012-01-26
AngioDynamics Morpheus Smart PICC CT 65cm 6F Dual Lumen --- Max CT Flow Rate: 6mL/SEC --- recall (Z-0896-2012)Angiodynamics Worldwide Headquarters2012-01-26
AngioDynamics Morpheus Smart PICC CT 65cm 5F Dual Lumen --- Max CT Flow Rate: 4mL/SEC --- recall (Z-0897-2012)Angiodynamics Worldwide Headquarters2012-01-26
AngioDynamics Morpheus Smart PICC CT 65cm 6F Dual Lumen --- Max CT Flow Rate: 6mL/SEC --- recall (Z-0898-2012)Angiodynamics Worldwide Headquarters2012-01-26
AngioDynamics Morpheus Smart PICC CT 5F Dual Lumen 65cm --- Max CT Flow Rate: 4mL/SEC --- recall (Z-0899-2012)Angiodynamics Worldwide Headquarters2012-01-26
AngioDynamics Morpheus Smart PICC CT 5F Dual Lumen w/ Reverse Taper 65cm --- Max CT Flow R recall (Z-0900-2012)Angiodynamics Worldwide Headquarters2012-01-26
AngioDynamics Morpheus Smart PICC CT 6F Dual Lumen w/ Reverse Taper 65cm --- Max CT Flow R recall (Z-0901-2012)Angiodynamics Worldwide Headquarters2012-01-26
AngioDynamics Morpheus Smart PICC CT 5F Dual Lumen w/ Reverse Taper 65cm --- Max CT Flow R recall (Z-0902-2012)Angiodynamics Worldwide Headquarters2012-01-26
AngioDynamics Morpheus Smart PICC CT with Stylet 5F Dual Lumen 65cm --- Max CT Flow Rate: recall (Z-0903-2012)Angiodynamics Worldwide Headquarters2012-01-26
AngioDynamics Morpheus Smart PICC CT with Stylet 5F Dual Lumen w/ Reverse Taper 65cm --- M recall (Z-0904-2012)Angiodynamics Worldwide Headquarters2012-01-26
AngioDynamics Morpheus Smart PICC CT 5F Dual Lumen w/ Reverse Taper 65cm --- Max CT Flow R recall (Z-0905-2012)Angiodynamics Worldwide Headquarters2012-01-26
AngioDynamics Morpheus Smart PICC CT 5F Dual Lumen w/ Reverse Taper 55cm --- Max CT Flow R recall (Z-0906-2012)Angiodynamics Worldwide Headquarters2012-01-26
AngioDynamics Morpheus Smart PICC CT with Stylet 5F Dual Lumen w/ Reverse Taper 55cm --- M recall (Z-0907-2012)Angiodynamics Worldwide Headquarters2012-01-26
AngioDynamics Morpheus Smart PICC CT 6F Triple Lumen w/ Reverse Taper 55cm --- Max CT Flow recall (Z-0908-2012)Angiodynamics Worldwide Headquarters2012-01-26
AngioDynamics Special Order Morpheus Smart PICC CT 65cm 5F Dual Lumen with Reverse Taper - recall (Z-0909-2012)Angiodynamics Worldwide Headquarters2012-01-26
AngioDynamics Special Order Morpheus Smart PICC CT 65cm 5F Dual Lumen with Reverse Taper - recall (Z-0910-2012)Angiodynamics Worldwide Headquarters2012-01-26
AngioDynamics Special Order Morpheus Smart PICC CT 65cm 6F Dual Lumen with Reverse Taper - recall (Z-0911-2012)Angiodynamics Worldwide Headquarters2012-01-26
AngioDynamics Special Order Morpheus Smart PICC CT 65cm 5F Dual Lumen with Reverse Taper - recall (Z-0912-2012)Angiodynamics Worldwide Headquarters2012-01-26