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Sign in to claim this brandPhilips Image Guided Therapy Corporation
United States·US-MF-000018632
Last updated September 17, 2026
Information
- Country
- United States
- Address
- 3721, Valley Centre Drive, San Diego, United States
- Website
- n/a
- —
- —
- [email protected]
- Phone
- n/a
- PRRC Contact
- Megan Olen
- EUDAMED SRN
- US-MF-000018632
- FDA FEI Number
- 3016257349
- DUNS Number
- —
Catalogue (177)
Page 2 of 4| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Stellarex 0.035" OTW drug-coated angioplasty balloon | AB35SX050100080 | FDA UDI | Class III | Active |
| Stellarex | AB35SX050150080 | FDA UDI | Class III | Active |
| VeriSight Pro Intracardiac Echocariography Catheter | VSICE3D | FDA UDI | Class II | Active |
| Stellarex | AB35SX060080080 | FDA UDI | Class III | Active |
| Stellarex 0.035" OTW drug-coated angioplasty balloon | AB35SX050150135 | FDA UDI | Class III | Active |
| Stellarex 0.035" OTW drug-coated angioplasty balloon | AB35SX050060080 | FDA UDI | Class III | Active |
| Stellarex | AB35SX040200080 | FDA UDI | Class III | Active |
| Stellarex 0.035" OTW drug-coated angioplasty balloon | AB35SX040060135 | FDA UDI | Class III | Active |
| Stellarex 0.035" OTW drug-coated angioplasty balloon | AB35SX040080080 | FDA UDI | Class III | Active |
| Stellarex | AB35SX050100135 | FDA UDI | Class III | Active |
| Stellarex | AB35SX040080135 | FDA UDI | Class III | Active |
| Stellarex | AB35SX040200135 | FDA UDI | Class III | Active |
| Stellarex | AB35SX060150080 | FDA UDI | Class III | Active |
| Stellarex | AB35SX050200080 | FDA UDI | Class III | Active |
| Stellarex | AB35SX050120135 | FDA UDI | Class III | Active |
| Stellarex | AB35SX060040135 | FDA UDI | Class III | Active |
| AngioSculpt Evo RX PTCA scoring balloon catheter with hydrophilic coating | 2200-2506-B | FDA UDI | Class III | Active |
| Stellarex 0.035" OTW drug-coated angioplasty balloon | AB35SX050080080 | FDA UDI | Class III | Active |
| Stellarex 0.035" OTW drug-coated angioplasty balloon | AB35SX050120135 | FDA UDI | Class III | Active |
| AngioSculpt Evo RX PTCA scoring balloon catheter with hydrophilic coating | 2200-3506-B | FDA UDI | Class III | Active |
| Stellarex | AB35SX050040135 | FDA UDI | Class III | Active |
| Stellarex 0.035" OTW drug-coated angioplasty balloon | AB35SX050080135 | FDA UDI | Class III | Active |
| Stellarex | AB35SX050080135 | FDA UDI | Class III | Active |
| Stellarex 0.035" OTW drug-coated angioplasty balloon | AB35SX040040080 | FDA UDI | Class III | Active |
| TightRail Guardian | 575-013 | FDA UDI | Class II | Unknown |
| Stellarex | AB35SX060060080 | FDA UDI | Class III | Active |
| Stellarex | AB35SX040120080 | FDA UDI | Class III | Active |
| CavaClear laser sheath | 500-516 | FDA UDI | Class II | Active |
| Stellarex 0.035" OTW drug-coated angioplasty balloon | AB35SX040120080 | FDA UDI | Class III | Active |
| Stellarex | AB35SX040120135 | FDA UDI | Class III | Active |
| Stellarex | AB35SX060150135 | FDA UDI | Class III | Active |
| Stellarex | AB35SX040150135 | FDA UDI | Class III | Active |
| Stellarex 0.035" OTW drug-coated angioplasty balloon | AB35SX040100135 | FDA UDI | Class III | Active |
| Patient Interface Module (PIMr) | 808884001 | FDA UDI | Class II | Active |
| Stellarex 0.035" OTW drug-coated angioplasty balloon | AB35SX050120080 | FDA UDI | Class III | Active |
| Stellarex 0.035" OTW drug-coated angioplasty balloon | AB35SX060040080 | FDA UDI | Class III | Active |
| CORE Mobile System Medical Equipment | 400-0100.08 | FDA UDI | Class II | Active |
| Stellarex 0.035" OTW drug-coated angioplasty balloon | AB35SX060200135 | FDA UDI | Class III | Active |
| Stellarex | AB35SX040100080 | FDA UDI | Class III | Active |
| TightRail Guardian | 575-011 | FDA UDI | Class II | Unknown |
| Stellarex | AB35SX060120080 | FDA UDI | Class III | Active |
| Stellarex 0.035" OTW drug-coated angioplasty balloon | AB35SX050060135 | FDA UDI | Class III | Active |
| Stellarex | AB35SX040040135 | FDA UDI | Class III | Active |
| Stellarex 0.035" OTW drug-coated angioplasty balloon | AB35SX050200135 | FDA UDI | Class III | Active |
| Patient Interface Module (PIMr) | 808884001 | FDA UDI | Class II | Active |
| AngioSculpt Evo RX PTCA scoring balloon catheter with hydrophilic coating | 2200-3006-B | FDA UDI | Class III | Active |
| Stellarex 0.035" OTW drug-coated angioplasty balloon | AB35SX050200080 | FDA UDI | Class III | Active |
| Stellarex 0.035" OTW drug-coated angioplasty balloon | AB35SX060150135 | FDA UDI | Class III | Active |
| Stellarex 0.035" OTW drug-coated angioplasty balloon | AB35SX060100080 | FDA UDI | Class III | Active |
| Stellarex | AB35SX060060135 | FDA UDI | Class III | Active |
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