| Device Type ID | 814 |
| Device Name | Catheter, Septostomy |
| Regulation Description | Septostomy Catheter. |
| Regulation Medical Specialty | Cardiovascular |
| Review Panel | Cardiovascular |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Cardiovascular Devices (DCD) Structural Heart Devices Branch (SHDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 870.5175 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | DXF |
| 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 | 814 |
| Device | Catheter, Septostomy |
| Product Code | DXF |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Septostomy Catheter. |
| CFR Regulation Number | 870.5175 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
BAYLIS MEDICAL COMPANY INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 55 |
Burst Container Or Vessel | 6 |
Packaging Problem | 3 |
Peeled / Delaminated | 2 |
Material Deformation | 1 |
Partial Blockage | 1 |
Balloon | 1 |
Device Displays Incorrect Message | 1 |
Deflation Problem | 1 |
| Total Device Problems | 71 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Baylis Medical Corp * | II | Nov-10-2016 |