| Device Type ID | 1707 |
| Device Name | Catheter, Retention Type, Balloon |
| 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 | EZL |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
|
| Device Type ID | 1707 |
| Device | Catheter, Retention Type, Balloon |
| Product Code | EZL |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Urological Catheter And Accessories. |
| CFR Regulation Number | 876.5130 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
AMSINO INTERNATIONAL, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
C. R. BARD, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
C.R. BARD, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
COOK, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
COVALON TECHNOLOGIES, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
HOSPIRA INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
JIANGXI YIKANG MEDICAL INSTRUMENT GROUP CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MEDLINE | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MEDLINE INDUSTRIES, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
POIESIS MEDICAL, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
POTRERO MEDICAL, INC. | ||
SUBSTANTIALLY EQUIVALENT - KIT | 1 | |
SEEDINGS LIFE SCIENCE VENTURES, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
TELEFLEX MEDICAL | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
TELEFLEX MEDICAL, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
WELL LEAD MEDICAL CO. LTD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Deflation Problem | 231 |
Burst Container Or Vessel | 201 |
Leak / Splash | 98 |
Break | 82 |
Inflation Problem | 36 |
Mushroomed | 33 |
Fluid Leak | 29 |
Material Deformation | 28 |
Difficult To Remove | 28 |
Device Dislodged Or Dislocated | 22 |
Defective Device | 21 |
Inaccurate Flow Rate | 20 |
Occlusion Within Device | 18 |
Bent | 17 |
Failure To Infuse | 17 |
Partial Blockage | 16 |
Patient-Device Incompatibility | 16 |
Material Invagination | 13 |
Hole In Material | 12 |
Manufacturing, Packaging Or Shipping Problem | 11 |
Device Markings / Labelling Problem | 10 |
Erratic Or Intermittent Display | 10 |
Device Operates Differently Than Expected | 10 |
Material Rupture | 9 |
Device Damaged Prior To Use | 8 |
Entrapment Of Device | 6 |
Torn Material | 6 |
Split | 6 |
Device Contamination With Chemical Or Other Material | 6 |
Material Protrusion / Extrusion | 5 |
Insufficient Information | 5 |
Restricted Flow Rate | 5 |
Migration Or Expulsion Of Device | 5 |
Tear, Rip Or Hole In Device Packaging | 5 |
Incorrect Measurement | 5 |
Catheter | 5 |
Balloon | 5 |
Adverse Event Without Identified Device Or Use Problem | 4 |
Use Of Device Problem | 4 |
Positioning Problem | 4 |
Material Perforation | 4 |
Unsealed Device Packaging | 4 |
Detachment Of Device Or Device Component | 3 |
Kinked | 3 |
Obstruction Of Flow | 3 |
Misassembled | 3 |
Material Twisted / Bent | 3 |
Improper Or Incorrect Procedure Or Method | 2 |
Delivered As Unsterile Product | 2 |
Activation Failure Including Expansion Failures | 2 |
No Flow | 2 |
Material Puncture / Hole | 2 |
Unintended Ejection | 2 |
Inadequate Instructions For Healthcare Professional | 2 |
Failure To Eject | 2 |
Difficult To Insert | 2 |
Difficult To Open Or Remove Packaging Material | 2 |
Blocked Connection | 2 |
Cut In Material | 2 |
Crack | 2 |
Material Separation | 2 |
Tube | 2 |
Device Packaging Compromised | 2 |
Incorrect Device Or Component Shipped | 2 |
Detachment Of Device Component | 2 |
Unintended Movement | 2 |
Inadequacy Of Device Shape And/or Size | 1 |
Device Contaminated During Manufacture Or Shipping | 1 |
Folded | 1 |
Device Damaged By Another Device | 1 |
Material Too Rigid Or Stiff | 1 |
Device Expiration Issue | 1 |
Labelling, Instructions For Use Or Training Problem | 1 |
Nonstandard Device | 1 |
Incorrect, Inadequate Or Imprecise Result Or Readings | 1 |
Inadequate User Interface | 1 |
Output Problem | 1 |
Packaging Problem | 1 |
Disconnection | 1 |
Short Fill | 1 |
Scratched Material | 1 |
Material Distortion | 1 |
Tip | 1 |
Appropriate Term/Code Not Available | 1 |
Physical Property Issue | 1 |
Wire | 1 |
Cuff | 1 |
Balloon Mushroomed | 1 |
Defective Component | 1 |
Failure To Advance | 1 |
Material Integrity Problem | 1 |
Physical Resistance | 1 |
Calcified | 1 |
Fracture | 1 |
| Total Device Problems | 1161 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | C.R. Bard, Inc. | II | Sep-15-2016 |
| 2 | Coloplast Manufacturing US, LLC | II | Apr-20-2016 |
| 3 | Covidien LLC | II | Mar-21-2016 |
| 4 | Degania Silicone, Ltd. | II | Sep-20-2018 |