| Device Type ID | 2003 |
| Device Name | Catheter, Hemodialysis, Non-implanted |
| Regulation Description | Blood Access Device And Accessories. |
| Regulation Medical Specialty | Gastroenterology/Urology |
| Review Panel | Gastroenterology/Urology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Reproductive, Gastro-Renal, And Urological Devices (DRGUD) Renal Devices Branch (RNDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 876.5540 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | MPB |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | Yes |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2003 |
| Device | Catheter, Hemodialysis, Non-implanted |
| Product Code | MPB |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Blood Access Device And Accessories. |
| CFR Regulation Number | 876.5540 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
COOK, INC. | ||
SUBSTANTIALLY EQUIVALENT - KIT WITH DRUGS | 1 | |
| Device Problems | |
|---|---|
Kinked | 37 |
Unraveled Material | 25 |
Physical Resistance | 24 |
Fluid Leak | 24 |
Break | 24 |
Crack | 22 |
Leak / Splash | 18 |
Product Quality Problem | 14 |
Difficult To Remove | 13 |
Device Operates Differently Than Expected | 8 |
Appropriate Term/Code Not Available | 8 |
Material Puncture / Hole | 7 |
Adverse Event Without Identified Device Or Use Problem | 7 |
Material Separation | 7 |
Migration Or Expulsion Of Device | 6 |
Infusion Or Flow Problem | 6 |
Bent | 5 |
Hole In Material | 5 |
Sticking | 4 |
Adapter (Adaptor) | 4 |
Fracture | 4 |
Delivered As Unsterile Product | 4 |
Material Distortion | 3 |
Safety Interlock | 3 |
Device Contamination With Chemical Or Other Material | 2 |
Physical Resistance / Sticking | 2 |
Device Handling Problem | 2 |
Device Issue | 2 |
Difficult To Insert | 2 |
Difficult To Advance | 2 |
Detachment Of Device Or Device Component | 2 |
Occlusion Within Device | 2 |
Material Frayed | 2 |
Material Split, Cut Or Torn | 2 |
Improper Or Incorrect Procedure Or Method | 2 |
Guidewire | 2 |
Material Integrity Problem | 2 |
Y-Piece Connector | 1 |
Failure To Adhere Or Bond | 1 |
Failure To Advance | 1 |
Device Operational Issue | 1 |
Patient-Device Incompatibility | 1 |
Unintended Ejection | 1 |
Melted | 1 |
Retraction Problem | 1 |
Activation, Positioning Or Separation Problem | 1 |
Device Dislodged Or Dislocated | 1 |
Connection Problem | 1 |
Fail-Safe Problem | 1 |
Needle | 1 |
Insufficient Information | 1 |
Mechanical Problem | 1 |
Stretched | 1 |
Split | 1 |
Connector | 1 |
Disconnection | 1 |
Device Damaged Prior To Use | 1 |
Failure To Disconnect | 1 |
Device Markings / Labelling Problem | 1 |
Protective Measures Problem | 1 |
Partial Blockage | 1 |
| Total Device Problems | 332 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Arrow International Inc | II | Apr-10-2018 |
| 2 | Arrow International Inc | II | Feb-20-2018 |
| 3 | Arrow International Inc | II | Jun-12-2017 |
| 4 | Cordis Corporation | II | Aug-18-2015 |
| 5 | Medical Components, Inc Dba MedComp | II | Aug-25-2018 |
| 6 | Medtronic Minimally Invasive Therapies Group | II | Mar-14-2018 |