| Device Type ID | 2006 |
| Device Name | Catheter, Hemodialysis, 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 | MSD |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | Yes |
| Life Support Device | Yes |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2006 |
| Device | Catheter, Hemodialysis, Implanted |
| Product Code | MSD |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Blood Access Device And Accessories. |
| CFR Regulation Number | 876.5540 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ARROW INTERNATIONAL, INC. (SUBSIDIARY OF TELEFLEX, INC.) | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ARROW INTL., INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
HEALTH LINE INTERNATIONAL CORPORATION | ||
SUBSTANTIALLY EQUIVALENT - KIT | 1 | |
MARVAO MEDICAL DEVICES, LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SUBSTANTIALLY EQUIVALENT - KIT | 5 | |
MEDCOMP | ||
SUBSTANTIALLY EQUIVALENT - KIT | 2 | |
MERIT MEDICAL SYSTEMS, INC. | ||
SUBSTANTIALLY EQUIVALENT - KIT | 2 | |
NAVILYST MEDICAL, INC. | ||
SUBSTANTIALLY EQUIVALENT - KIT | 1 | |
PHASE ONE MEDICAL | ||
SUBSTANTIALLY EQUIVALENT - KIT | 1 | |
| Device Problems | |
|---|---|
Fluid Leak | 190 |
Leak / Splash | 164 |
Break | 158 |
Crack | 126 |
Catheter | 100 |
Material Deformation | 77 |
Defective Component | 57 |
Fracture | 57 |
Hole In Material | 49 |
Kinked | 44 |
Migration Or Expulsion Of Device | 36 |
Appropriate Term/Code Not Available | 34 |
Device Dislodged Or Dislocated | 32 |
Device Operates Differently Than Expected | 32 |
Adapter (Adaptor) | 29 |
Air Leak | 28 |
Failure To Adhere Or Bond | 27 |
Occlusion Within Device | 24 |
Adverse Event Without Identified Device Or Use Problem | 16 |
Material Separation | 16 |
Detachment Of Device Or Device Component | 16 |
Disconnection | 16 |
Connection Problem | 15 |
Cuff | 15 |
Material Frayed | 14 |
Infusion Or Flow Problem | 14 |
Detachment Of Device Component | 12 |
Human-Device Interface Problem | 11 |
Material Puncture / Hole | 10 |
Restricted Flow Rate | 10 |
Split | 9 |
Insufficient Information | 9 |
Component Missing | 9 |
Inaccurate Flow Rate | 7 |
Torn Material | 7 |
Difficult To Remove | 6 |
Y-Piece Connector | 5 |
Unraveled Material | 5 |
Material Rupture | 5 |
Hub | 4 |
Sticking | 4 |
Unintended Movement | 4 |
Material Fragmentation | 4 |
Luer Valve | 4 |
Port | 4 |
Contamination During Use | 4 |
Tear, Rip Or Hole In Device Packaging | 4 |
Material Integrity Problem | 4 |
Gas Leak | 4 |
Physical Resistance | 3 |
Product Quality Problem | 3 |
Guidewire | 3 |
Obstruction Of Flow | 3 |
Tube | 3 |
Junction | 3 |
Component Incompatible | 3 |
Failure To Infuse | 3 |
Insufficient Flow Or Under Infusion | 3 |
Device Damaged Prior To Use | 2 |
Material Distortion | 2 |
Mechanics Altered | 2 |
Positioning Problem | 2 |
Scratched Material | 2 |
Loose Or Intermittent Connection | 2 |
Device Or Device Fragments Location Unknown | 2 |
Cut In Material | 2 |
Improper Flow Or Infusion | 2 |
Mechanical Problem | 2 |
Device Contamination With Chemical Or Other Material | 2 |
Partial Blockage | 2 |
Unsealed Device Packaging | 2 |
Incomplete Or Missing Packaging | 2 |
Use Of Device Problem | 2 |
Suction Problem | 2 |
Pin | 2 |
Improper Or Incorrect Procedure Or Method | 2 |
Patient-Device Incompatibility | 2 |
Bent | 1 |
Burst Container Or Vessel | 1 |
Failure To Advance | 1 |
Lock | 1 |
Device Inoperable | 1 |
Deflation Problem | 1 |
Disassembly | 1 |
Difficult To Flush | 1 |
No Flow | 1 |
Tip | 1 |
T-Piece Connector | 1 |
Material Split, Cut Or Torn | 1 |
Delivered As Unsterile Product | 1 |
Backflow | 1 |
Device Issue | 1 |
Folded | 1 |
Material Too Rigid Or Stiff | 1 |
Clamp | 1 |
Complete Blockage | 1 |
Joint | 1 |
Aspiration Issue | 1 |
Device Misassembled During Manufacturing / Shipping | 1 |
Physical Resistance / Sticking | 1 |
| Total Device Problems | 1619 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Argon Medical Devices, Inc | II | Sep-24-2014 |
| 2 | Arrow International Inc | II | Jan-22-2015 |
| 3 | Covidien LLC | II | Jul-01-2015 |
| 4 | Medical Components, Inc Dba MedComp | II | Mar-30-2015 |
| 5 | Medical Components, Inc Dba MedComp | II | Sep-04-2014 |