| Device Type ID | 1704 |
| Device Name | Catheter, Coude |
| 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 | EZC |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
|
| Device Type ID | 1704 |
| Device | Catheter, Coude |
| Product Code | EZC |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Urological Catheter And Accessories. |
| CFR Regulation Number | 876.5130 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
TELEFLEX MEDICAL | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Deflation Problem | 146 |
Burst Container Or Vessel | 78 |
Partial Blockage | 76 |
Difficult To Remove | 68 |
Failure To Infuse | 58 |
Inaccurate Flow Rate | 39 |
Break | 33 |
Leak / Splash | 32 |
Patient-Device Incompatibility | 15 |
Material Rupture | 14 |
Misassembled | 12 |
Material Invagination | 11 |
Device Damaged Prior To Use | 11 |
Incorrect Measurement | 9 |
Use Of Device Problem | 6 |
Device Dislodged Or Dislocated | 6 |
Gel Leak | 6 |
Material Deformation | 6 |
Disconnection | 5 |
Deformation Due To Compressive Stress | 5 |
Inadequate Instructions For Healthcare Professional | 4 |
Catheter | 4 |
Balloon | 4 |
Erratic Or Intermittent Display | 4 |
Restricted Flow Rate | 4 |
Inability To Irrigate | 4 |
Insufficient Information | 4 |
Labelling, Instructions For Use Or Training Problem | 3 |
Device Contamination With Chemical Or Other Material | 3 |
Mushroomed | 2 |
Nonstandard Device | 2 |
Short Fill | 2 |
Degraded | 2 |
Defective Component | 2 |
Tear, Rip Or Hole In Device Packaging | 1 |
Improper Device Output | 1 |
Product Quality Problem | 1 |
Material Discolored | 1 |
Material Twisted / Bent | 1 |
Component Missing | 1 |
Insufficient Flow Or Under Infusion | 1 |
Component Falling | 1 |
No Device Output | 1 |
Torn Material | 1 |
Device Expiration Issue | 1 |
Material Too Rigid Or Stiff | 1 |
| Total Device Problems | 692 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | C.R. Bard, Inc. | II | Jun-06-2018 |