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FDA 510(k)

STERILE EQUIPMENT COVERS

K-Number: K052395 · 2005-12-01

ApplicantVolcano Corporation
Decision Date2005-12-01
Product CodeKKX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

STERILE EQUIPMENT COVERS is the device name listed in this FDA 510(k) record. The listed applicant is Volcano Corporation. It received FDA 510(k) clearance on 2005-12-01 under 510(k) number K052395. The device is classified under product code KKX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STERILE EQUIPMENT COVERS?

STERILE EQUIPMENT COVERS is a medical device that received FDA 510(k) clearance on 2005-12-01. The listed applicant is Volcano Corporation. The 510(k) number is K052395.

When did STERILE EQUIPMENT COVERS receive FDA 510(k) clearance?

STERILE EQUIPMENT COVERS received FDA 510(k) clearance on 2005-12-01, under 510(k) number K052395.

Who is the listed applicant for STERILE EQUIPMENT COVERS?

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 STERILE EQUIPMENT COVERS?

The FDA product code for STERILE EQUIPMENT COVERS is KKX.

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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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