| Device Type ID | 743 |
| Device Name | Stylet, Catheter |
| Regulation Description | Catheter Stylet. |
| Regulation Medical Specialty | Cardiovascular |
| Review Panel | Cardiovascular |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Cardiovascular Devices (DCD) Cardiac Electrophysiology Devices Branch (CEDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 870.1380 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | DRB |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |
| Device Type ID | 743 |
| Device | Stylet, Catheter |
| Product Code | DRB |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Catheter Stylet. |
| CFR Regulation Number | 870.1380 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
COOK, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SPECTRANETICS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 23 |
Break | 5 |
Mechanical Problem | 4 |
Material Separation | 3 |
Material Integrity Problem | 3 |
Difficult To Remove | 2 |
Appropriate Term/Code Not Available | 2 |
Detachment Of Device Or Device Component | 2 |
Packaging Problem | 1 |
Insufficient Information | 1 |
Device Expiration Issue | 1 |
Lead | 1 |
Patient Device Interaction Problem | 1 |
Material Fragmentation | 1 |
Device Contamination With Chemical Or Other Material | 1 |
Device Subassembly | 1 |
Activation, Positioning Or Separation Problem | 1 |
Device Dislodged Or Dislocated | 1 |
Tip | 1 |
Material Frayed | 1 |
Device Inoperable | 1 |
Improper Or Incorrect Procedure Or Method | 1 |
Failure To Advance | 1 |
| Total Device Problems | 59 |