Bridge Plus occlusion balloon 590-002
by Philips Image Guided Therapy Corporation GUDID
Listed (no authorization)
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00810060550816 | Date9 Oct 2025 | StatusIn distribution |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — GUDID listing Listed
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- Trade Name
- Bridge Plus occlusion balloon
- Generic Name
- Intravascular occluding balloon catheter, image-guided
- Model / Ref / Catalog
- 590-002
- Primary DI / UDI-DI
- 00810060550816
- 510(k) Number
- FDA Product Code
- MJN
- GMDN Term
- Intravascular occluding balloon catheter, image-guided
- Device Class
- Class II
- Regulation Number
- 870.4450
- Commercial Distribution
- In Commercial Distribution
- Size
- Introducer Sheath Compatibility — 12 FrenchBalloon Diameter — 29 MillimeterBalloon Length — 80 MillimeterCatheter Working Length — 90 Centimeter
Other devices from Philips Image Guided Therapy Corporation
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Properties
Other properties (8)
- Implantable: No
- Contains Latex: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Serial Number: No