s5 Intravascular Ultrasound Imaging and Pressure Systems, s5i Intravascular Ultrasound Imaging and Pressure Systems, CORE Precision Guided Therapy System, CORE Mobile Precision Guided Therapy System
FDA 510(k) clearance K173860 · decided 2018-04-11
Clearance details
- K-number
- K173860
- Device name
- s5 Intravascular Ultrasound Imaging and Pressure Systems, s5i Intravascular Ultrasound Imaging and Pressure Systems, CORE Precision Guided Therapy System, CORE Mobile Precision Guided Therapy System
- Applicant
- Volcano Corporation
- Decision
- Substantially Equivalent
- Date received
- 2017-12-20
- Decision date
- 2018-04-11
- Days to decision
- 112 days
- Clearance type
- Traditional
- Product code
- IYO
- Device class
- 2
- Regulation number
- 892.1560
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- San Diego, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.