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FDA 510(k)

MICRO PRIME

K-Number: K041650 · 2004-08-16

ApplicantInnovx Medical, Inc.
Decision Date2004-08-16
Product CodeDWF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MICRO PRIME is the device name listed in this FDA 510(k) record. The listed applicant is Innovx Medical, Inc.. It received FDA 510(k) clearance on 2004-08-16 under 510(k) number K041650. The device is classified under product code DWF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MICRO PRIME?

MICRO PRIME is a medical device that received FDA 510(k) clearance on 2004-08-16. The listed applicant is Innovx Medical, Inc.. The 510(k) number is K041650.

When did MICRO PRIME receive FDA 510(k) clearance?

MICRO PRIME received FDA 510(k) clearance on 2004-08-16, under 510(k) number K041650.

Who is the listed applicant for MICRO PRIME?

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

What is the FDA product code for MICRO PRIME?

The FDA product code for MICRO PRIME is DWF.

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Related Devices (Code: DWF)

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Official Source

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

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