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FDA 510(k)

NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking Probe, 17mm balloon,NvisionVLE Marking Probe, 14mm balloon, NvisionVLE Inflation System

K-Number: K153479 · 2016-02-16

ApplicantNinepoint Medical, Inc.
Decision Date2016-02-16
Product CodeNQQ
Advisory CommitteeRA
DecisionUnknown

Device Summary

NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking Probe, 17mm balloon,NvisionVLE Marking Probe, 14mm balloon, NvisionVLE Inflation System is the device name listed in this FDA 510(k) record. The listed applicant is Ninepoint Medical, Inc.. It received FDA 510(k) clearance on 2016-02-16 under 510(k) number K153479. The device is classified under product code NQQ. It was reviewed by the RA advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking Probe, 17mm balloon,NvisionVLE Marking Probe, 14mm balloon, NvisionVLE Inflation System?

NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking Probe, 17mm balloon,NvisionVLE Marking Probe, 14mm balloon, NvisionVLE Inflation System is a medical device that received FDA 510(k) clearance on 2016-02-16. The listed applicant is Ninepoint Medical, Inc.. The 510(k) number is K153479.

When did NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking Probe, 17mm balloon,NvisionVLE Marking Probe, 14mm balloon, NvisionVLE Inflation System receive FDA 510(k) clearance?

NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking Probe, 17mm balloon,NvisionVLE Marking Probe, 14mm balloon, NvisionVLE Inflation System received FDA 510(k) clearance on 2016-02-16, under 510(k) number K153479.

Who is the listed applicant for NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking Probe, 17mm balloon,NvisionVLE Marking Probe, 14mm balloon, NvisionVLE Inflation System?

The FDA 510(k) record lists Ninepoint Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking Probe, 17mm balloon,NvisionVLE Marking Probe, 14mm balloon, NvisionVLE Inflation System?

The FDA product code for NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking Probe, 17mm balloon,NvisionVLE Marking Probe, 14mm balloon, NvisionVLE Inflation System is NQQ.

Other records listing Ninepoint Medical, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K191117NvisionVLE Low-profile Optical ProbeK182616NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation SystemK182261NvisionVLE Imaging System, NvisionVLE Optical Probe

Related Devices (Code: NQQ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253459OPTIS Mobile Next Imaging System (1014932); OPTIS Integrated Next Imaging System (1014933); Ultreon 3.0 Software Upgrade Kit (ULTR300001)ABBOTT MEDICALK251730LIA Console (542-7)Leadoptik, Inc.K253101HyperVue™ Imaging System - IntegratedSpectrawave, Inc.K252851deepLive (OSP12 + DMS)Damae MedicalK251198HyperVue™ SoftwareSpectrawave, Inc.K250684OPUSWAVE Dual Sensor Imaging SystemTerumo Cardiovascular Systems Thi Plant

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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