Device, Anastomotic, Microvascular

Device Code: 5753

Product Code(s): MVR

Device Classification Information

Device Type ID5753
Device NameDevice, Anastomotic, Microvascular
Regulation DescriptionImplantable Clip.
Regulation Medical SpecialtyGeneral & Plastic Surgery
Review PanelGeneral & Plastic Surgery
Premarket Review Office Of Device Evaluation (ODE)
Division Of Cardiovascular Devices (DCD)
Cardiac Diagnostics Devices Branch (CDDB)
Submission Type510(k)
CFR Regulation Number878.4300 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeMVR
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID5753
DeviceDevice, Anastomotic, Microvascular
Product CodeMVR
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionImplantable Clip.
CFR Regulation Number878.4300 [🔎]
Premarket Reviews
ManufacturerDecision
BAXTER HEALTHCARE CORPORATION
 
SUBSTANTIALLY EQUIVALENT
2
Device Problems
Device Operates Differently Than Expected
49
Adverse Event Without Identified Device Or Use Problem
13
Activation, Positioning Or Separation Problem
4
Material Twisted / Bent
4
Detachment Of Device Or Device Component
3
Break
2
Crack
1
Difficult To Position
1
Delivery System Failure
1
Naturally Worn
1
Failure To Conduct
1
Loose Or Intermittent Connection
1
Separation Failure
1
Bent
1
False Positive Result
1
Failure To Sense
1
Improper Or Incorrect Procedure Or Method
1
Failure To Advance
1
Device Dislodged Or Dislocated
1
Total Device Problems 88
TPLC Last Update: 2019-04-02 21:11:57

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