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FDA 510(k)

LUMENVU CATHETER GUIDANCE SYSTEM

K-Number: K093510 · 2010-08-23

ApplicantSonosite,Inc.
Decision Date2010-08-23
Product CodeOMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

LUMENVU CATHETER GUIDANCE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Sonosite,Inc.. It received FDA 510(k) clearance on 2010-08-23 under 510(k) number K093510. The device is classified under product code OMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LUMENVU CATHETER GUIDANCE SYSTEM?

LUMENVU CATHETER GUIDANCE SYSTEM is a medical device that received FDA 510(k) clearance on 2010-08-23. The listed applicant is Sonosite,Inc.. The 510(k) number is K093510.

When did LUMENVU CATHETER GUIDANCE SYSTEM receive FDA 510(k) clearance?

LUMENVU CATHETER GUIDANCE SYSTEM received FDA 510(k) clearance on 2010-08-23, under 510(k) number K093510.

Who is the listed applicant for LUMENVU CATHETER GUIDANCE SYSTEM?

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

What is the FDA product code for LUMENVU CATHETER GUIDANCE SYSTEM?

The FDA product code for LUMENVU CATHETER GUIDANCE SYSTEM is OMF.

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Other records listing Sonosite,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.

K113156SONOSITE EDGE ULTRASOUND SYSTEMK110645BIO Z CARDIO PROFILE HEMODYNAMIC MONITORK102390SONOSITE NANOMAXX SERIES ULTRASOUND SYSTEMK101757SONOSITE NANOMAXX SERIES ULTRASOUND SYSTEM, SONOSITE MAXX SERIES ULTRASOUND SYSTEMK092058SONOSITE NANOMAXX SERIES ULTRASOUND SYSTEMK082098SONOSITE MAXX SERIES ULTRASOUND SYSTEM

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Related Devices (Code: OMF)

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.

K083121NEO MAPCATH SENSOR STYLETCorpak Medsystems

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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