Device Listing 1066682520
Listing Summary#
- Listing key
- 1066682520
- Premarket submission
- K250409
- Device
- Disposable Balloon Catheter (B5-2Q); Disposable Balloon Catheter (B7-2Q); Disposable Balloon Catheter (B7-2LA)
- Applicant
- Olympus Medical Systems Corporation
- Product code
- FGE
- Decision date
- 2025-10-21