| Device Type ID | 876 |
| Device Name | Catheter, Intravascular Occluding, Temporary |
| Regulation Description | Vascular Clamp. |
| 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 | 870.4450 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | MJN |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |
| Device Type ID | 876 |
| Device | Catheter, Intravascular Occluding, Temporary |
| Product Code | MJN |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Vascular Clamp. |
| CFR Regulation Number | 870.4450 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ACCESS CLOSURE, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ACCESSCLOSURE, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BOSTON SCIENTIFIC CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BOSTON SCIENTIFIC CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
EDWARDS LIFESCIENCES | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
EDWARDS LIFESCIENCES LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
LEMAITRE VASCULAR, INC. | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
NUMED, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
PRYTIME MEDICAL DEVICES, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
RENOVORX, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
SPECTRANETICS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Leak / Splash | 72 |
Deflation Problem | 71 |
Material Rupture | 48 |
Adverse Event Without Identified Device Or Use Problem | 39 |
Burst Container Or Vessel | 24 |
Hole In Material | 16 |
Inflation Problem | 11 |
Balloon | 6 |
Fluid Leak | 6 |
Break | 5 |
Material Puncture / Hole | 5 |
Use Of Device Problem | 3 |
Delivered As Unsterile Product | 3 |
Product Quality Problem | 3 |
Material Perforation | 3 |
Device Markings / Labelling Problem | 3 |
Material Separation | 3 |
Device Damaged By Another Device | 3 |
Device Issue | 2 |
Peeled / Delaminated | 2 |
Physical Resistance / Sticking | 2 |
Detachment Of Device Or Device Component | 2 |
Torn Material | 2 |
Insufficient Information | 2 |
Difficult To Remove | 2 |
Physical Resistance | 2 |
Device Operates Differently Than Expected | 2 |
Difficult To Open Or Close | 2 |
Catheter | 2 |
No Apparent Adverse Event | 1 |
Degraded | 1 |
Unknown (for Use When The Device Problem Is Not Known) | 1 |
Activation, Positioning Or Separation Problem | 1 |
Patient-Device Incompatibility | 1 |
Failure To Advance | 1 |
Failure To Align | 1 |
Split | 1 |
Crack | 1 |
Mechanical Problem | 1 |
Difficult To Position | 1 |
Difficult To Advance | 1 |
Flaked | 1 |
Therapy Delivered To Incorrect Body Area | 1 |
Material Deformation | 1 |
Optical Problem | 1 |
Positioning Failure | 1 |
Incomplete Or Missing Packaging | 1 |
Device Packaging Compromised | 1 |
Device Handling Problem | 1 |
| Total Device Problems | 366 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | AccessClosure, Inc., A Cardinal Health Company | II | Oct-21-2016 |
| 2 | LeMaitre Vascular, Inc. | II | Nov-16-2018 |
| 3 | RenovoRx, Inc. | II | Dec-31-2015 |
| 4 | Spectranetics Corporation | I | Aug-26-2017 |
| 5 | Spectranetics Corporation | II | Nov-28-2016 |