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FDA 510(k)

MODIFICATION TO MIRA-FLEX 18 MICROCATHETER

K-Number: K060224 · 2006-03-06

ApplicantCook Incorporated
Decision Date2006-03-06
Product CodeKRA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO MIRA-FLEX 18 MICROCATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Cook Incorporated. It received FDA 510(k) clearance on 2006-03-06 under 510(k) number K060224. The device is classified under product code KRA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION TO MIRA-FLEX 18 MICROCATHETER?

MODIFICATION TO MIRA-FLEX 18 MICROCATHETER is a medical device that received FDA 510(k) clearance on 2006-03-06. The listed applicant is Cook Incorporated. The 510(k) number is K060224.

When did MODIFICATION TO MIRA-FLEX 18 MICROCATHETER receive FDA 510(k) clearance?

MODIFICATION TO MIRA-FLEX 18 MICROCATHETER received FDA 510(k) clearance on 2006-03-06, under 510(k) number K060224.

Who is the listed applicant for MODIFICATION TO MIRA-FLEX 18 MICROCATHETER?

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

What is the FDA product code for MODIFICATION TO MIRA-FLEX 18 MICROCATHETER?

The FDA product code for MODIFICATION TO MIRA-FLEX 18 MICROCATHETER is KRA.

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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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