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Philips 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
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: n/a
PRRC Contact: Megan Olen
EUDAMED SRN: US-MF-000018632
FDA FEI Number: 3016257349
DUNS Number: —

Catalogue (177)

Page 3 of 4

Device	Model / Reference	Registries	Class	Status
AngioSculpt Evo RX PTCA scoring balloon catheter with hydrophilic coating	2200-2520-B	FDA UDI	Class III	Active
Stellarex 0.035" OTW drug-coated angioplasty balloon	AB35SX040150135	FDA UDI	Class III	Active
Stellarex 0.035" OTW drug-coated angioplasty balloon	AB35SX060120135	FDA UDI	Class III	Active
Stellarex 0.035" OTW drug-coated angioplasty balloon	AB35SX060060080	FDA UDI	Class III	Active
AngioSculpt Evo RX PTCA scoring balloon catheter with hydrophilic coating	2200-2006-B	FDA UDI	Class III	Active
Stellarex 0.035" OTW drug-coated angioplasty balloon	AB35SX050100135	FDA UDI	Class III	Active
AngioSculpt Evo RX PTCA scoring balloon catheter with hydrophilic coating	2200-2010-B	FDA UDI	Class III	Active
Stellarex 0.035" OTW drug-coated angioplasty balloon	AB35SX040100080	FDA UDI	Class III	Active
Stellarex	AB35SX050200135	FDA UDI	Class III	Active
Stellarex 0.035" OTW drug-coated angioplasty balloon	AB35SX040080135	FDA UDI	Class III	Active
Stellarex	AB35SX050080080	FDA UDI	Class III	Active
Stellarex 0.035" OTW drug-coated angioplasty balloon	AB35SX060100135	FDA UDI	Class III	Active
TightRail Guardian	575-009	FDA UDI	Class II	Unknown
AngioSculpt Evo RX PTCA scoring balloon catheter with hydrophilic coating	2200-3520-B	FDA UDI	Class III	Active
Stellarex	AB35SX050150135	FDA UDI	Class III	Active
AngioSculpt Evo RX PTCA scoring balloon catheter with hydrophilic coating	2200-3015-B	FDA UDI	Class III	Active
Visions PV .035 Digital IVUS Catheter	81234	FDA UDI	Class II	Active
AngioSculpt Evo RX PTCA scoring balloon catheter with hydrophilic coating	2200-3515-B	FDA UDI	Class III	Active
Stellarex	AB35SX040150080	FDA UDI	Class III	Active
Quick-Cross support catheter	518-034	EUDAMEDFDA UDI	Class IIa	Active
Quick-Cross Extreme support catheter	518-082	EUDAMEDFDA UDI	Class IIa	Active
Quick-Cross Select support catheter	518-077	EUDAMEDFDA UDI	Class IIa	Active
Quick-Cross Select support catheter	518-093	EUDAMEDFDA UDI	Class IIa	Active
Quick-Cross support catheter	518-066	EUDAMEDFDA UDI	Class IIa	Active
Quick-Cross Extreme support catheter	518-078	EUDAMEDFDA UDI	Class IIa	Active
Quick-Cross Extreme support catheter	518-086	EUDAMEDFDA UDI	Class IIa	Active
Quick-Cross Extreme support catheter	518-084	EUDAMEDFDA UDI	Class IIa	Active
Phoenix Atherectomy System	P18130K	EUDAMEDFDA UDI	Class IIa	Active
Quick-Cross support catheter	518-033	EUDAMEDFDA UDI	Class IIa	Active
LLD lead cutter	518-024	EUDAMED	Class IIa	Active
Quick-Cross Select support catheter	518-081	EUDAMEDFDA UDI	Class IIa	Active
Phoenix Atherectomy Catheter	P22130	EUDAMEDFDA UDI	Class IIa	Active
Quick-Cross Extreme support catheter	518-090	EUDAMEDFDA UDI	Class IIa	Active
Turbo-Power Laser atherectomy catheter	423-050	EUDAMED	Class IIb	Active
Quick-Cross support catheter	518-036	EUDAMEDFDA UDI	Class IIa	Active
VeriSight Intracardiac Echocardiography Catheter (VSICE2D); VeriSight Pro Intracardiac Echocardiography Catheter (VSICE3D)	K251103	FDA 510(k)	Class II	Active
VeriSight Intracardiac Echocardiography (ICE) Catheter, VeriSight Pro ICE Catheter	K200812	FDA 510(k)	Class II	Active
IntraSight Plus	K253714	EUDAMEDFDA 510(k)	Class II	Active
Reconnaissance PV .018 OTW Digital IVUS Catheter	K200410	FDA 510(k)	Class II	Active
LLD lead locking device	518-019	EUDAMED	Class IIa	Active
Turbo-Power Laser atherectomy catheter	420-050	EUDAMED	Class IIb	Active
Phoenix Pre-Deflected Atherectomy System	PD22130K	EUDAMEDFDA UDI	Class IIa	Active
Phoenix Atherectomy System	P18149K	EUDAMEDFDA UDI	Class IIa	Active
LLD lead locking device	518-023	EUDAMED	Class IIa	Active
Quick-Cross Select support catheter	518-089	EUDAMEDFDA UDI	Class IIa	Active
Quick-Cross Select support catheter	518-091	EUDAMEDFDA UDI	Class IIa	Active
Phoenix Atherectomy Catheter	P18130	EUDAMEDFDA UDI	Class IIa	Active
LLD accessory kit	518-027	EUDAMED	Class IIa	Active
Quick-Cross Select support catheter	518-087	EUDAMEDFDA UDI	Class IIa	Active
Quick-Cross Select support catheter	518-083	EUDAMEDFDA UDI	Class IIa	Active

Philips Image Guided Therapy Corporation

Information

Catalogue (177)

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