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FDA 510(k)

PRIMEWIRE PRESTIGE PLUS

K-Number: K111395 · 2011-08-01

ApplicantVolcano Corporation
Decision Date2011-08-01
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PRIMEWIRE PRESTIGE PLUS is the device name listed in this FDA 510(k) record. The listed applicant is Volcano Corporation. It received FDA 510(k) clearance on 2011-08-01 under 510(k) number K111395. The device is classified under product code DQX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRIMEWIRE PRESTIGE PLUS?

PRIMEWIRE PRESTIGE PLUS is a medical device that received FDA 510(k) clearance on 2011-08-01. The listed applicant is Volcano Corporation. The 510(k) number is K111395.

When did PRIMEWIRE PRESTIGE PLUS receive FDA 510(k) clearance?

PRIMEWIRE PRESTIGE PLUS received FDA 510(k) clearance on 2011-08-01, under 510(k) number K111395.

Who is the listed applicant for PRIMEWIRE PRESTIGE PLUS?

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 PRIMEWIRE PRESTIGE PLUS?

The FDA product code for PRIMEWIRE PRESTIGE PLUS is DQX.

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Related Devices (Code: DQX)

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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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