| Device Type ID | 2658 |
| Device Name | Port & Catheter, Implanted, Subcutaneous, Intravascular |
| Regulation Description | Subcutaneous, Implanted, Intravascular Infusion Port And Catheter. |
| Regulation Medical Specialty | General Hospital |
| Review Panel | General Hospital |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID) General Hospital Devices Branch (GHDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 880.5965 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | LJT |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 2658 |
| Device | Port & Catheter, Implanted, Subcutaneous, Intravascular |
| Product Code | LJT |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Subcutaneous, Implanted, Intravascular Infusion Port And Catheter. |
| CFR Regulation Number | 880.5965 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
C.R. BARD, INC. | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
COOK, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
NAVILYST MEDICAL, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
STEALTH THERAPEUTICS, INCORPORATED | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Break | 222 |
Fluid Leak | 180 |
Fracture | 150 |
Defective Component | 81 |
Appropriate Term/Code Not Available | 65 |
Difficult To Remove | 62 |
Detachment Of Device Component | 57 |
Component Missing | 55 |
Crack | 49 |
Suction Problem | 42 |
Detachment Of Device Or Device Component | 40 |
Leak / Splash | 39 |
Material Separation | 35 |
Migration Or Expulsion Of Device | 30 |
Aspiration Issue | 29 |
Material Frayed | 26 |
Failure To Infuse | 25 |
Catheter | 21 |
Material Deformation | 20 |
Component Incompatible | 20 |
Material Rupture | 20 |
Device Dislodged Or Dislocated | 18 |
Port | 16 |
Device Contamination With Chemical Or Other Material | 15 |
Device Issue | 13 |
Adverse Event Without Identified Device Or Use Problem | 12 |
Use Of Device Problem | 11 |
Patient-Device Incompatibility | 10 |
Expiration Date Error | 9 |
Improper Or Incorrect Procedure Or Method | 9 |
Material Integrity Problem | 8 |
Material Fragmentation | 8 |
Peeled / Delaminated | 8 |
Tear, Rip Or Hole In Device Packaging | 7 |
Migration | 6 |
Device Operates Differently Than Expected | 6 |
Material Twisted / Bent | 6 |
Kinked | 6 |
Disconnection | 6 |
Insufficient Information | 5 |
Incomplete Or Missing Packaging | 5 |
Infusion Or Flow Problem | 5 |
Device Appears To Trigger Rejection | 5 |
Difficult To Flush | 5 |
Material Puncture / Hole | 4 |
Label | 4 |
Hole In Material | 4 |
Incorrect Device Or Component Shipped | 4 |
Material Too Rigid Or Stiff | 3 |
Material Perforation | 3 |
Split | 3 |
Restricted Flow Rate | 3 |
Unable To Obtain Readings | 3 |
Device Markings / Labelling Problem | 3 |
Backflow | 3 |
Occlusion Within Device | 3 |
No Display / Image | 3 |
Failure To Adhere Or Bond | 3 |
Burst Container Or Vessel | 3 |
Deformation Due To Compressive Stress | 2 |
Unraveled Material | 2 |
Connector | 2 |
Malfunction | 2 |
Malposition Of Device | 2 |
Device Or Device Fragments Location Unknown | 2 |
Other (for Use When An Appropriate Device Code Cannot Be Identified) | 2 |
Unsealed Device Packaging | 2 |
Tube | 2 |
Complete Blockage | 2 |
Misassembly By Users | 2 |
Device Misassembled During Manufacturing / Shipping | 2 |
Partial Blockage | 1 |
Therapy Delivered To Incorrect Body Area | 1 |
Mushroomed | 1 |
Device Handling Problem | 1 |
False Negative Result | 1 |
Material Opacification | 1 |
Filtration Problem | 1 |
Improper Flow Or Infusion | 1 |
Delivery System Failure | 1 |
Defective Device | 1 |
Labelling, Instructions For Use Or Training Problem | 1 |
Difficult To Insert | 1 |
Entrapment Of Device | 1 |
Connection Problem | 1 |
Misassembled | 1 |
Delivered As Unsterile Product | 1 |
Activation, Positioning Or Separation Problem | 1 |
Obstruction Of Flow | 1 |
Retraction Problem | 1 |
Reservoir | 1 |
Degraded | 1 |
Device Operational Issue | 1 |
Human-Device Interface Problem | 1 |
Wrinkled | 1 |
Device, Or Device Fragments Remain In Patient | 1 |
Decoupling | 1 |
Material Discolored | 1 |
Misconnection | 1 |
Guidewire | 1 |
| Total Device Problems | 1569 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Angiodynamics Inc. (Navilyst Medical Inc.) | II | Oct-05-2018 |
| 2 | B. Braun Interventional Systems | II | Aug-13-2015 |
| 3 | Bard Access Systems | II | Mar-13-2015 |
| 4 | Bard Access Systems | II | Mar-27-2014 |
| 5 | Bard Peripheral Vascular Inc | II | May-09-2018 |
| 6 | Cook Vascular Inc. | II | Mar-27-2018 |
| 7 | Medical Components, Inc Dba MedComp | II | Mar-29-2018 |
| 8 | Medical Components, Inc Dba MedComp | II | Feb-06-2018 |
| 9 | Medical Components, Inc Dba MedComp | II | Mar-08-2017 |
| 10 | Medical Components, Inc Dba MedComp | II | Apr-27-2015 |
| 11 | Smiths Medical ASD Inc. | II | Mar-15-2018 |
| 12 | Smiths Medical ASD, Inc. | II | Oct-21-2015 |