| Device Type ID | 2551 |
| Device Name | Stopcock, I.v. Set |
| Regulation Description | Intravascular Administration Set. |
| 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 | 880.5440 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | FMG |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
|
| Device Type ID | 2551 |
| Device | Stopcock, I.v. Set |
| Product Code | FMG |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Intravascular Administration Set. |
| CFR Regulation Number | 880.5440 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
DYNAREX | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ELCAM MEDICAL ACAL | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Fluid Leak | 110 |
Disconnection | 60 |
Stopcock | 56 |
Connection Problem | 30 |
Leak / Splash | 28 |
Tube | 25 |
Connector | 16 |
Break | 16 |
Stopcock Valve | 14 |
Detachment Of Device Component | 13 |
Crack | 13 |
Device Damaged Prior To Use | 10 |
Disassembly | 9 |
No Flow | 9 |
Detachment Of Device Or Device Component | 6 |
Component(s), Broken | 5 |
Kinked | 5 |
Loose Or Intermittent Connection | 5 |
Material Separation | 5 |
Device Dislodged Or Dislocated | 5 |
Port | 5 |
Fracture | 5 |
Failure To Prime | 5 |
Infusion Or Flow Problem | 5 |
Device Operates Differently Than Expected | 4 |
Manifold | 4 |
Reflux Within Device | 4 |
Filling Problem | 4 |
Blocked Connection | 4 |
Improper Flow Or Infusion | 3 |
Mechanical Problem | 3 |
Insufficient Flow Or Under Infusion | 3 |
Failure To Infuse | 3 |
Device Contamination With Chemical Or Other Material | 3 |
Air Leak | 3 |
Improper Or Incorrect Procedure Or Method | 3 |
Valve | 2 |
Y-Piece Connector | 2 |
Cap | 2 |
Luer Valve | 2 |
Device Packaging Compromised | 2 |
Plug | 2 |
Material Deformation | 2 |
Failure To Disconnect | 2 |
Split | 1 |
Incorrect Device Or Component Shipped | 1 |
Complete Blockage | 1 |
Excess Flow Or Over-Infusion | 1 |
Junction | 1 |
Physical Property Issue | 1 |
Material Split, Cut Or Torn | 1 |
Adverse Event Without Identified Device Or Use Problem | 1 |
Air Eliminator | 1 |
Backflow | 1 |
Misassembled | 1 |
Bent | 1 |
Contamination During Use | 1 |
Defective Component | 1 |
| Total Device Problems | 531 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Elcam Medical, Inc. | II | Apr-20-2017 |
| 2 | ICU Medical De Mexico, S.A. De C.V. | II | Aug-16-2018 |
| 3 | ICU Medical, Inc. | II | Oct-04-2018 |
| 4 | ICU Medical, Inc. | II | Aug-07-2018 |
| 5 | ICU Medical, Inc. | II | Apr-10-2018 |
| 6 | ICU Medical, Inc. | II | Nov-17-2017 |
| 7 | ICU Medical, Inc. | II | Jun-26-2017 |
| 8 | ICU Medical, Inc. | II | Jan-10-2017 |
| 9 | ICU Medical, Inc. | II | May-07-2015 |
| 10 | ICU Medical, Inc. | I | Sep-19-2014 |
| 11 | Value Plastics, Inc. | II | Mar-09-2016 |
| 12 | Vygon MFG, Inc., Dba/ Churchill Medical Systems, Inc. | II | Feb-21-2018 |