| Device Type ID | 1705 |
| Device Name | Catheter, Straight |
| 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 | EZD |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
|
| Device Type ID | 1705 |
| Device | Catheter, Straight |
| Product Code | EZD |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Urological Catheter And Accessories. |
| CFR Regulation Number | 876.5130 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ADAPTA MEDICAL, INC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
C.R. BARD, INC. | ||
SUBSTANTIALLY EQUIVALENT | 4 | |
COMPACTCATH INC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MEDLINE | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MEDLINE INDUSTRIES, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SHAOXING FUQING HEALTH PRODUCTS CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
WELL LEAD MEDICAL CO. LTD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Product Quality Problem | 205 |
Patient-Device Incompatibility | 58 |
Adverse Event Without Identified Device Or Use Problem | 49 |
Device Damaged Prior To Use | 23 |
Inaccurate Flow Rate | 18 |
Material Twisted / Bent | 15 |
Incorrect Measurement | 12 |
Misassembled | 10 |
Partial Blockage | 9 |
Insufficient Information | 8 |
Difficult To Remove | 6 |
Deformation Due To Compressive Stress | 4 |
Break | 4 |
Difficult To Insert | 4 |
Nonstandard Device | 3 |
Device Contamination With Chemical Or Other Material | 3 |
Tear, Rip Or Hole In Device Packaging | 3 |
Fracture | 2 |
Catheter | 2 |
Inadequate Instructions For Healthcare Professional | 2 |
Use Of Device Problem | 2 |
Leak / Splash | 2 |
Material Separation | 2 |
Cut In Material | 2 |
Detachment Of Device Or Device Component | 1 |
Short Fill | 1 |
Sharp Edges | 1 |
Restricted Flow Rate | 1 |
Device Issue | 1 |
Off-Label Use | 1 |
Material Deformation | 1 |
Material Puncture / Hole | 1 |
Appropriate Term/Code Not Available | 1 |
Migration Or Expulsion Of Device | 1 |
Expiration Date Error | 1 |
| Total Device Problems | 459 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | C.R. Bard, Inc. | II | Apr-04-2018 |
| 2 | Cure Medical LLC | II | Dec-16-2014 |