| Device Type ID | 3724 |
| Device Name | Device, Neurovascular Embolization |
| Regulation Description | Neurovascular Embolization Device. |
| Regulation Medical Specialty | Neurology |
| Review Panel | Neurology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Neurological And Physical Medicine Devices (DNPMD) Neurointerventional Devices Branch (NIDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 882.5950 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | HCG |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3724 |
| Device | Device, Neurovascular Embolization |
| Product Code | HCG |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Neurovascular Embolization Device. |
| CFR Regulation Number | 882.5950 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
BLOCKADE MEDICAL | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
CODMAN & SHURTLEFF, INC. | ||
SUBSTANTIALLY EQUIVALENT | 4 | |
JOHNSON & JOHNSON PROFESSIONALS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
MICROVENTION, INC. | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
PENUMBRA, INC. | ||
SUBSTANTIALLY EQUIVALENT | 6 | |
STRYKER NEUROVASCULAR | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
| Device Problems | |
|---|---|
Failure To Advance | 1964 |
Physical Resistance | 1613 |
Detachment Of Device Component | 1033 |
Coil | 727 |
Adverse Event Without Identified Device Or Use Problem | 702 |
Break | 441 |
Kinked | 440 |
Premature Activation | 429 |
Stretched | 428 |
Physical Resistance / Sticking | 393 |
Positioning Failure | 349 |
Separation Failure | 332 |
Mechanical Jam | 311 |
Device Handling Problem | 289 |
Device Operates Differently Than Expected | 273 |
Difficult To Advance | 240 |
Mechanical Problem | 220 |
Device Damaged Prior To Use | 205 |
Migration Or Expulsion Of Device | 205 |
Bent | 177 |
Premature Separation | 162 |
Detachment Of Device Or Device Component | 146 |
Out-Of-Box Failure | 139 |
Retraction Problem | 134 |
Material Deformation | 122 |
Difficult Or Delayed Activation | 119 |
Device Issue | 116 |
Difficult To Position | 103 |
Unraveled Material | 89 |
Difficult To Remove | 84 |
Inadequacy Of Device Shape And/or Size | 62 |
Activation, Positioning Or Separation Problem | 60 |
Failure To Fold | 59 |
Material Protrusion / Extrusion | 59 |
Deformation Due To Compressive Stress | 56 |
Device-Device Incompatibility | 51 |
Material Separation | 50 |
Fracture | 44 |
Material Twisted / Bent | 43 |
Difficult Or Delayed Positioning | 43 |
Entrapment Of Device | 43 |
Appropriate Term/Code Not Available | 42 |
Device Operational Issue | 30 |
Unintended Movement | 29 |
Malposition Of Device | 28 |
Positioning Problem | 27 |
Migration | 27 |
Difficult Or Delayed Separation | 24 |
Defective Device | 21 |
Material Too Rigid Or Stiff | 21 |
Insufficient Information | 18 |
Device Damaged By Another Device | 16 |
Device Dislodged Or Dislocated | 16 |
Use Of Device Problem | 15 |
Device Fell | 15 |
Material Integrity Problem | 14 |
Patient-Device Incompatibility | 13 |
Device Difficult To Setup Or Prepare | 11 |
No Apparent Adverse Event | 11 |
Difficult To Insert | 10 |
Knotted | 9 |
Structural Problem | 8 |
Device Markings / Labelling Problem | 6 |
Component Falling | 5 |
Collapse | 5 |
Difficult To Fold Or Unfold | 5 |
Device Contamination With Chemical Or Other Material | 5 |
Partial Blockage | 5 |
Air Leak | 5 |
Component Missing | 5 |
Material Frayed | 5 |
Contamination During Use | 5 |
Physical Property Issue | 4 |
Noise, Audible | 4 |
Separation Problem | 4 |
Failure To Disconnect | 4 |
Hub | 3 |
Inadequate User Interface | 3 |
Delivery System Failure | 3 |
Difficult To Open Or Remove Packaging Material | 3 |
Unsealed Device Packaging | 3 |
Human Factors Issue | 3 |
Folded | 3 |
Leak / Splash | 3 |
Sticking | 3 |
Catheter | 3 |
Looping | 3 |
Connection Problem | 3 |
Improper Or Incorrect Procedure Or Method | 3 |
Defective Component | 2 |
Device Contamination With Body Fluid | 2 |
Misconnection | 2 |
Tear, Rip Or Hole In Device Packaging | 2 |
Uncoiled | 2 |
Material Disintegration | 2 |
Chemical Problem | 2 |
Electrical /Electronic Property Problem | 2 |
Wire | 2 |
None | 2 |
Coagulation In Device Or Device Ingredient | 2 |
| Total Device Problems | 13088 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Stryker Neurovascular | II | Jul-11-2016 |
| 2 | Stryker Neurovascular | II | Apr-19-2016 |
| 3 | Stryker Neurovascular | II | Dec-16-2014 |