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FDA 510(k)

NVISION VLE IMAGING SYSTEM, NVISION VLE CATHETER

K-Number: K112770 · 2011-12-16

ApplicantNinepoint Medical, Inc.
Decision Date2011-12-16
Product CodeNQQ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

NVISION VLE IMAGING SYSTEM, NVISION VLE CATHETER 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 2011-12-16 under 510(k) number K112770. The device is classified under product code NQQ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NVISION VLE IMAGING SYSTEM, NVISION VLE CATHETER?

NVISION VLE IMAGING SYSTEM, NVISION VLE CATHETER is a medical device that received FDA 510(k) clearance on 2011-12-16. The listed applicant is Ninepoint Medical, Inc.. The 510(k) number is K112770.

When did NVISION VLE IMAGING SYSTEM, NVISION VLE CATHETER receive FDA 510(k) clearance?

NVISION VLE IMAGING SYSTEM, NVISION VLE CATHETER received FDA 510(k) clearance on 2011-12-16, under 510(k) number K112770.

Who is the listed applicant for NVISION VLE IMAGING SYSTEM, NVISION VLE CATHETER?

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 NVISION VLE IMAGING SYSTEM, NVISION VLE CATHETER?

The FDA product code for NVISION VLE IMAGING SYSTEM, NVISION VLE CATHETER is NQQ.

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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 ProbeK153479NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking Probe, 17mm balloon,NvisionVLE Marking Probe, 14mm balloon, NvisionVLE Inflation SystemK120800NVISION VLE IMAGING SYSTEMK121195NVISION VLE IMAGING SYSTEM NVISION VLE CATHETER

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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

View on FDA Database →

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

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