| Device Type ID | 855 |
| Device Name | Ring, Annuloplasty |
| Regulation Description | Annuloplasty Ring. |
| Regulation Medical Specialty | Cardiovascular |
| Review Panel | Cardiovascular |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Cardiovascular Devices (DCD) Structural Heart Devices Branch (SHDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 870.3800 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | KRH |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 855 |
| Device | Ring, Annuloplasty |
| Product Code | KRH |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Annuloplasty Ring. |
| CFR Regulation Number | 870.3800 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
GENESEE BIOMEDICAL, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MEDTRONIC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MEDTRONIC, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SORIN | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SORIN GROUP ITALIA S.R.L | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SORIN GROUP ITALIA S.R.L. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Insufficient Information | 703 |
Adverse Event Without Identified Device Or Use Problem | 285 |
Inadequacy Of Device Shape And/or Size | 58 |
Device Operates Differently Than Expected | 50 |
Appropriate Term/Code Not Available | 46 |
Incomplete Coaptation | 21 |
Gradient Increase | 20 |
Perivalvular Leak | 20 |
Patient-Device Incompatibility | 16 |
No Apparent Adverse Event | 9 |
Calcified | 7 |
Material Separation | 7 |
Leak / Splash | 6 |
Material Deformation | 6 |
Material Integrity Problem | 5 |
Device Dislodged Or Dislocated | 5 |
Occlusion Within Device | 3 |
Malposition Of Device | 3 |
Material Distortion | 2 |
Off-Label Use | 2 |
Degraded | 2 |
Obstruction Of Flow | 2 |
Structural Problem | 2 |
Fracture | 2 |
Expiration Date Error | 1 |
Bent | 1 |
Human-Device Interface Problem | 1 |
Improper Or Incorrect Procedure Or Method | 1 |
Use Of Device Problem | 1 |
Material Fragmentation | 1 |
Separation Failure | 1 |
Detachment Of Device Component | 1 |
Device Contamination With Biological Material | 1 |
Biocompatibility | 1 |
Material Rupture | 1 |
Device Damaged Prior To Use | 1 |
Break | 1 |
Crack | 1 |
Incorrect, Inadequate Or Imprecise Result Or Readings | 1 |
Split | 1 |
Detachment Of Device Or Device Component | 1 |
Torn Material | 1 |
| Total Device Problems | 1300 |