| Device Type ID | 1984 |
| Device Name | Catheter, Subclavian |
| 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 3 Medical Device |
| Product Code | LFJ |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 1984 |
| Device | Catheter, Subclavian |
| Product Code | LFJ |
| FDA Device Classification | Class 3 Medical Device |
| Regulation Description | Blood Access Device And Accessories. |
| CFR Regulation Number | 876.5540 [🔎] |
| Device Problems | |
|---|---|
Kinked | 29 |
Physical Resistance | 18 |
Unraveled Material | 15 |
Leak / Splash | 10 |
Material Deformation | 7 |
Material Frayed | 5 |
Physical Resistance / Sticking | 4 |
Break | 4 |
Fluid Leak | 4 |
Adverse Event Without Identified Device Or Use Problem | 3 |
Bent | 3 |
Occlusion Within Device | 2 |
Crack | 2 |
Difficult To Insert | 2 |
Sticking | 2 |
Air Leak | 2 |
Material Separation | 2 |
Device Packaging Compromised | 1 |
Expulsion | 1 |
Spring | 1 |
Component Incompatible | 1 |
Material Fragmentation | 1 |
Hole In Material | 1 |
Incorrect Device Or Component Shipped | 1 |
Entrapment Of Device | 1 |
Difficult To Advance | 1 |
Detachment Of Device Or Device Component | 1 |
Delivered As Unsterile Product | 1 |
Connection Problem | 1 |
Material Puncture / Hole | 1 |
Device Dislodged Or Dislocated | 1 |
Appropriate Term/Code Not Available | 1 |
Migration Or Expulsion Of Device | 1 |
Difficult To Remove | 1 |
Lock | 1 |
Defective Component | 1 |
Failure To Advance | 1 |
| Total Device Problems | 134 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Medical Components, Inc Dba MedComp | II | Feb-10-2015 |