| Device Type ID | 1967 |
| Device Name | Catheter, Urological |
| Regulation Description | Urological Catheter 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) Urology And Lithotripsy Devices Branch (ULDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 876.5130 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | KOD |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
|
| Device Type ID | 1967 |
| Device | Catheter, Urological |
| Product Code | KOD |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Urological Catheter And Accessories. |
| CFR Regulation Number | 876.5130 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
BOSTON SCIENTIFIC CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BOSTON SCIENTIFIC CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
CONVATEC INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
CONVATEC LIMITED | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
CONVATEC LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
COOK, INC. | ||
SUBSTANTIALLY EQUIVALENT | 4 | |
ROBLING MEDICAL, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
UROGEN PHARMA LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Product Quality Problem | 237 |
Deflation Problem | 111 |
Device Damaged Prior To Use | 102 |
Incorrect Measurement | 92 |
Nonstandard Device | 91 |
Short Fill | 87 |
Misassembled | 86 |
Break | 83 |
Patient-Device Incompatibility | 71 |
Burst Container Or Vessel | 48 |
Adverse Event Without Identified Device Or Use Problem | 43 |
Material Twisted / Bent | 41 |
Leak / Splash | 36 |
Defective Device | 33 |
Insufficient Information | 27 |
Device Contamination With Chemical Or Other Material | 23 |
Difficult To Insert | 22 |
Material Too Rigid Or Stiff | 18 |
Device Operates Differently Than Expected | 18 |
Inaccurate Flow Rate | 18 |
Use Of Device Problem | 16 |
Balloon | 15 |
Bent | 15 |
Inflation Problem | 14 |
Catheter | 14 |
Difficult To Open Or Remove Packaging Material | 14 |
Material Deformation | 13 |
Difficult To Remove | 13 |
Material Integrity Problem | 13 |
Tear, Rip Or Hole In Device Packaging | 11 |
Failure To Infuse | 11 |
Material Rupture | 10 |
Improper Or Incorrect Procedure Or Method | 9 |
Deformation Due To Compressive Stress | 8 |
Delivered As Unsterile Product | 7 |
Partial Blockage | 7 |
Unsealed Device Packaging | 6 |
Detachment Of Device Or Device Component | 6 |
Occlusion Within Device | 6 |
Component Missing | 6 |
Fluid Leak | 5 |
Inability To Irrigate | 5 |
Material Fragmentation | 5 |
Folded | 5 |
Material Separation | 4 |
Separation Failure | 4 |
Peeled / Delaminated | 4 |
Sticking | 4 |
Unintended Movement | 4 |
Gel Leak | 4 |
Packaging Problem | 4 |
Device Dislodged Or Dislocated | 4 |
Tip | 4 |
Contamination During Use | 4 |
Appropriate Term/Code Not Available | 3 |
Activation, Positioning Or Separation Problem | 3 |
Device Difficult To Setup Or Prepare | 3 |
Inadequate Instructions For Healthcare Professional | 3 |
Retraction Problem | 3 |
Kinked | 3 |
Restricted Flow Rate | 3 |
Device Markings / Labelling Problem | 3 |
Sharp Edges | 3 |
Device Contaminated During Manufacture Or Shipping | 3 |
Mushroomed | 2 |
Plunger | 2 |
Device Packaging Compromised | 2 |
Scratched Material | 2 |
Difficult To Advance | 2 |
Malposition Of Device | 2 |
Device Disinfection Or Sterilization Issue | 2 |
Torn Material | 2 |
Split | 2 |
Incorrect, Inadequate Or Imprecise Result Or Readings | 2 |
Material Perforation | 2 |
Degraded | 2 |
No Flow | 2 |
Obstruction Of Flow | 2 |
Invalid Sensing | 2 |
Material Frayed | 2 |
Defective Component | 2 |
Low Readings | 2 |
Fracture | 2 |
Material Disintegration | 1 |
Migration Or Expulsion Of Device | 1 |
Failure To Advance | 1 |
Device Stops Intermittently | 1 |
Material Discolored | 1 |
Valve | 1 |
Connection Problem | 1 |
Cuff | 1 |
Shaft | 1 |
Syringe | 1 |
Difficult Or Delayed Positioning | 1 |
Structural Problem | 1 |
Delamination | 1 |
Melted | 1 |
Material Puncture / Hole | 1 |
Material Split, Cut Or Torn | 1 |
Microbial Contamination Of Device | 1 |
| Total Device Problems | 1646 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | C.R. Bard, Inc. | II | Sep-03-2015 |
| 2 | C.R. Bard, Inc. | II | Aug-14-2015 |
| 3 | COVIDIEN LLC | II | Sep-20-2018 |
| 4 | ConvaTec, Inc | II | Mar-21-2019 |
| 5 | Convatec Inc. | II | Mar-20-2014 |
| 6 | Teleflex Medical | II | Dec-16-2016 |
| 7 | Teleflex Medical | II | Sep-18-2014 |
| 8 | Teleflex Medical | II | Jun-09-2014 |