FDA Registration
Active
🇺🇸 United States
VOLCANO CORPORATION
Reg #: 2939520
·
FEI: 2939520
·
Expires 2026
Products
11
Proprietary Names
35
Establishment Types
1
Classifications
11
Registration Details
- Registration Name
- VOLCANO CORPORATION
- Registration Number
- 2939520
- FEI Number
- 2939520
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 2451 Mercantile Drive
- City
- Rancho Cordova
- State
- CA
- ZIP
- 95742
- Country
- US
Regulatory Submissions
- 510(k) Number
- K153369
Owner / Operator
- Firm Name
- Philips Medical Systems International BV
- Operator Number
- 2939520
- Address
- Veenpluis 6
- City
- Best
- State
- NL-NOTA
- Postal Code
- 5684PC
- Country
- NL
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Computer, Blood-Pressure | DSK | Class 2 | Cardiovascular | No | 2016-01-14 |
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | Class 2 | Radiology | No | 2016-01-14 |
| Cable, Transducer And Electrode, Patient, (Including Connector) | DSA | Class 2 | Cardiovascular | No | 2016-01-14 |
| Interventional Fluoroscopic X-Ray System | OWB | Class 2 | Radiology | No | 2026-04-30 |
| Drape, Surgical, Antimicrobial | KKX | Class 2 | General, Plastic Surgery | No | 2007-12-14 |
| Catheter, Ultrasound, Intravascular | OBJ | Class 2 | Cardiovascular | No | 2015-10-16 |
| Transducer, Pressure, Catheter Tip | DXO | Class 2 | Cardiovascular | No | 2022-11-09 |
| Wire, Guide, Catheter | DQX | Class 2 | Cardiovascular | No | 2022-11-09 |
| Transducer, Ultrasonic, Diagnostic | ITX | Class 2 | Radiology | No | 2020-08-19 |
| Catheter For Crossing Total Occlusions | PDU | Class 2 | Cardiovascular | No | 2016-12-06 |
| Catheter, Peripheral, Atherectomy | MCW | Class 2 | Cardiovascular | No | 2015-05-21 |
Proprietary Names
Software v3.5
IntraSight Plus
Sterile Equipment Covers
Visions PV 18 Digital IVUS Catheter
OmniWire Pressure Guide Wire
Reconnaissance PV 18 OTW Digital IVUS Catheter
R-100 Automatic Pullback Device
300000629191, Upgrade Kit, SyncVision v4.1
Visions PV 14P RX Digital IVUS Catheter
Upgrade Kit, SyncVision v4.2
IntraSight Mobile System
806426-008 ComboMap Software v1.9 Document Kit
806426-012 ComboMap Software v2.1 Upgrade Kit
803523-001 ComboMap Cart Kit
806426-004 ComboMap Software v1.9 Upgrade Kit
807062-001 ComboMap Sterile Cover
803521-001, 802745-001 ComboMap System
SyncRx
SyncVision System
s5i
Visions PV 35 Digital IVUS Catheter
Visions Pioneer Plus Catheter
Phoenix Atherectomy System 2.2mm x 149cm
Phoenix Atherectomy System 1.8mm x 149cm
Phoenix Atherectomy Catheter 1.8mm x 149cm
Phoenix Handle with Wire Support Clip
Phoenix Atherectomy Catheter 2.2mm x 149cm
IntraSight
CORE M2 Vascular System
Volcano CORE Control Pad, Accessory to the Volcano CORE/CORE Mobile Precision Guided Therapy Systems
CORE
s5/s5i
Refinity ST Rotational IVUS Catheter
Eagle Eye Platinum ST RX Digital IVUS Catheter
Eagle Eye Platinum RX Digital IVUS Catheter
Establishment Types
Manufacture Medical Device