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FDA 510(k)

NvisionVLE Low-profile Optical Probe

K-Number: K191117 · 2019-07-19

ApplicantNinepoint Medical, Inc.
Decision Date2019-07-19
Product CodeNQQ
Advisory CommitteeRA
DecisionUnknown

Device Summary

NvisionVLE Low-profile Optical Probe 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 2019-07-19 under 510(k) number K191117. 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 Low-profile Optical Probe?

NvisionVLE Low-profile Optical Probe is a medical device that received FDA 510(k) clearance on 2019-07-19. The listed applicant is Ninepoint Medical, Inc.. The 510(k) number is K191117.

When did NvisionVLE Low-profile Optical Probe receive FDA 510(k) clearance?

NvisionVLE Low-profile Optical Probe received FDA 510(k) clearance on 2019-07-19, under 510(k) number K191117.

Who is the listed applicant for NvisionVLE Low-profile Optical Probe?

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 Low-profile Optical Probe?

The FDA product code for NvisionVLE Low-profile Optical Probe 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.

K182616NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation SystemK182261NvisionVLE Imaging System, NvisionVLE Optical ProbeK153479NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking Probe, 17mm balloon,NvisionVLE Marking Probe, 14mm balloon, NvisionVLE Inflation System

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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