FDA Product Code MMX: Device, Percutaneous Retrieval
Under FDA product code MMX, percutaneous retrieval devices are cleared for the endovascular retrieval of foreign bodies and misplaced objects from the cardiovascular system.
These snare, basket, or grasper devices are delivered through catheters to capture and remove fragmented catheters, guide wires, embolized devices, and other intravascular foreign bodies without open surgery.
MMX devices are Class II medical devices, regulated under 21 CFR 870.5150 and reviewed by the FDA Cardiovascular panel.
Leading manufacturers include Argon Medical Devices, Inc., Abbott Medical and Cook Incorporated.
FDA 510(k) Cleared Device, Percutaneous Retrieval Devices (Product Code MMX)
About Product Code MMX - Regulatory Context
510(k) Submission Activity
32 total 510(k) submissions under product code MMX since 2002, with 32 receiving FDA clearance (average review time: 107 days).
Submission volume has declined in recent years - 2 submissions in the last 24 months compared to 4 in the prior period.
FDA Review Time
Recent submissions under MMX have taken an average of 91 days to reach a decision - down from 108 days historically, suggesting improved FDA processing for this classification.
MMX devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →