NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking Probe, 17mm balloon,NvisionVLE Marking Probe, 14mm balloon, NvisionVLE Inflation System
FDA 510(k) clearance K153479 · decided 2016-02-16
Clearance details
- K-number
- K153479
- Device name
- NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking Probe, 17mm balloon,NvisionVLE Marking Probe, 14mm balloon, NvisionVLE Inflation System
- Applicant
- Ninepoint Medical, Inc.
- Decision
- Unknown
- Date received
- 2015-12-02
- Decision date
- 2016-02-16
- Days to decision
- 76 days
- Clearance type
- Traditional
- Product code
- NQQ
- Device class
- 2
- Regulation number
- 892.1560
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Bedford, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.