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FDA 510(k)

IN VISION GOLD WITH SPIN VISION, MODEL 891 SV

K-Number: K052348 · 2005-12-02

ApplicantVolcano Corporation
Decision Date2005-12-02
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

IN VISION GOLD WITH SPIN VISION, MODEL 891 SV is the device name listed in this FDA 510(k) record. The listed applicant is Volcano Corporation. It received FDA 510(k) clearance on 2005-12-02 under 510(k) number K052348. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IN VISION GOLD WITH SPIN VISION, MODEL 891 SV?

IN VISION GOLD WITH SPIN VISION, MODEL 891 SV is a medical device that received FDA 510(k) clearance on 2005-12-02. The listed applicant is Volcano Corporation. The 510(k) number is K052348.

When did IN VISION GOLD WITH SPIN VISION, MODEL 891 SV receive FDA 510(k) clearance?

IN VISION GOLD WITH SPIN VISION, MODEL 891 SV received FDA 510(k) clearance on 2005-12-02, under 510(k) number K052348.

Who is the listed applicant for IN VISION GOLD WITH SPIN VISION, MODEL 891 SV?

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

What is the FDA product code for IN VISION GOLD WITH SPIN VISION, MODEL 891 SV?

The FDA product code for IN VISION GOLD WITH SPIN VISION, MODEL 891 SV is IYO.

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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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