Device Type ID | 5753 |
Device Name | Device, Anastomotic, Microvascular |
Regulation Description | Implantable Clip. |
Regulation Medical Specialty | General & Plastic Surgery |
Review Panel | General & Plastic Surgery |
Premarket Review | Office Of Device Evaluation (ODE) Division Of Cardiovascular Devices (DCD) Cardiac Diagnostics Devices Branch (CDDB) |
Submission Type | 510(k) |
CFR Regulation Number | 878.4300 [🔎] |
FDA Device Classification | Class 2 Medical Device |
Product Code | MVR |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 5753 |
Device | Device, Anastomotic, Microvascular |
Product Code | MVR |
FDA Device Classification | Class 2 Medical Device |
Regulation Description | Implantable Clip. |
CFR Regulation Number | 878.4300 [🔎] |
Premarket Reviews | ||
---|---|---|
Manufacturer | Decision | |
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 |