| Device Type ID | 851 |
| Device Name | Device, Vascular, For Promoting Embolization |
| Regulation Description | Vascular Embolization Device. |
| Regulation Medical Specialty | Cardiovascular |
| Review Panel | Cardiovascular |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Cardiovascular Devices (DCD) Vascular Surgery Devices Branch (VSDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 870.3300 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | KRD |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 851 |
| Device | Device, Vascular, For Promoting Embolization |
| Product Code | KRD |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Vascular Embolization Device. |
| CFR Regulation Number | 870.3300 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ARTVENTIVE MEDICAL GROUP, INC | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
BIOCOMPATIBLES, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
BIOSPHERE MEDICAL, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BIOSPHERE MEDICAL, S.A. | ||
SUBSTANTIALLY EQUIVALENT | 4 | |
BOSTON SCIENTIFIC CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BOSTON SCIENTIFIC CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
CELONOVA BIOSCIENCES, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
COOK, INC. | ||
SUBSTANTIALLY EQUIVALENT | 5 | |
EMBA MEDICAL LIMITED | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ENDOSHAPE, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
MICROVENTION, INC. | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
VASCULAR SOLUTIONS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 4 | |
| Device Problems | |
|---|---|
Detachment Of Device Component | 451 |
Separation Failure | 413 |
Coil | 409 |
Adverse Event Without Identified Device Or Use Problem | 290 |
Stretched | 211 |
Detachment Of Device Or Device Component | 144 |
Migration Or Expulsion Of Device | 122 |
Material Protrusion / Extrusion | 111 |
Premature Activation | 97 |
Break | 97 |
Positioning Failure | 75 |
Failure To Advance | 65 |
Kinked | 59 |
Entrapment Of Device | 57 |
Physical Resistance / Sticking | 57 |
Difficult To Remove | 56 |
Unraveled Material | 54 |
Device-Device Incompatibility | 54 |
Material Twisted / Bent | 52 |
Physical Resistance | 51 |
Difficult To Position | 46 |
Device Issue | 44 |
Activation, Positioning Or Separation Problem | 43 |
Migration | 41 |
Material Deformation | 39 |
Material Separation | 33 |
Positioning Problem | 27 |
Difficult To Advance | 25 |
Unintended Movement | 24 |
Premature Separation | 22 |
Therapy Delivered To Incorrect Body Area | 17 |
Fracture | 16 |
Difficult Or Delayed Positioning | 14 |
Off-Label Use | 14 |
Material Integrity Problem | 12 |
Activation Failure Including Expansion Failures | 11 |
Device Dislodged Or Dislocated | 9 |
Device Operates Differently Than Expected | 9 |
Leak / Splash | 9 |
Material Fragmentation | 8 |
Malposition Of Device | 8 |
Shelf Life Exceeded | 8 |
Device Contamination With Chemical Or Other Material | 7 |
No Apparent Adverse Event | 6 |
Deformation Due To Compressive Stress | 6 |
Wire | 6 |
Difficult Or Delayed Separation | 5 |
Pusher | 5 |
Delivery System Failure | 5 |
Insufficient Information | 5 |
Separation Problem | 5 |
Flaked | 5 |
Difficult To Insert | 5 |
Component Missing | 4 |
Obstruction Of Flow | 4 |
Retraction Problem | 4 |
Contamination / Decontamination Problem | 4 |
Component Misassembled | 3 |
Use Of Device Problem | 3 |
Uncoiled | 3 |
Failure To Disconnect | 3 |
Mechanical Problem | 3 |
Inadequacy Of Device Shape And/or Size | 3 |
Fitting Problem | 3 |
Knotted | 3 |
Device Damaged By Another Device | 3 |
Human Factors Issue | 2 |
Incomplete Or Missing Packaging | 2 |
Device Contaminated During Manufacture Or Shipping | 2 |
Other (for Use When An Appropriate Device Code Cannot Be Identified) | 2 |
Microbial Contamination Of Device | 2 |
Device Damaged Prior To Use | 2 |
Disconnection | 2 |
Device Markings / Labelling Problem | 2 |
Missing Information | 2 |
Improper Or Incorrect Procedure Or Method | 2 |
Tear, Rip Or Hole In Device Packaging | 2 |
Tip | 2 |
Material Frayed | 2 |
Delivered As Unsterile Product | 1 |
Perivalvular Leak | 1 |
Collimator | 1 |
Label | 1 |
Syringe | 1 |
Catheter | 1 |
Stent | 1 |
Material Puncture / Hole | 1 |
Delamination | 1 |
Contamination During Use | 1 |
Defective Component | 1 |
Device Operational Issue | 1 |
Spring Loading Mechanism Problem | 1 |
Shunt | 1 |
Bent | 1 |
Impedance Problem | 1 |
Hub | 1 |
Difficult Or Delayed Activation | 1 |
Torn Material | 1 |
Material Too Soft / Flexible | 1 |
Aborted Charge | 1 |
| Total Device Problems | 3554 |