DQP · Kit, Balloon Repair, Catheter
Cardiovascular · 21 CFR 870.1350 · Class 3
Overview
| Product Code | DQP |
|---|---|
| Device Name | Kit, Balloon Repair, Catheter |
| Regulation | 21 CFR 870.1350 |
| Device Class | Class 3 |
| Review Panel | Cardiovascular |
Identification
A catheter balloon repair kit is a device used to repair or replace the balloon of a balloon catheter. The kit contains the materials, such as glue and balloons, necessary to effect the repair or replacement.
Classification Rationale
Class III (premarket approval).
Recent Cleared Devices (0 of 0)
No cleared devices on record.
