FDA 510(k)

MICROVIEW II/MICRORAIL II CATHETERS

K-Number: K942231 · 1994-08-01

ApplicantCardiovascular Imaging Systems, Inc.

Decision Date1994-08-01

Product CodeDQO

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

MICROVIEW II/MICRORAIL II CATHETERS is the device name listed in this FDA 510(k) record. The listed applicant is Cardiovascular Imaging Systems, Inc.. It received FDA 510(k) clearance on 1994-08-01 under 510(k) number K942231. The device is classified under product code DQO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MICROVIEW II/MICRORAIL II CATHETERS?

MICROVIEW II/MICRORAIL II CATHETERS is a medical device that received FDA 510(k) clearance on 1994-08-01. The listed applicant is Cardiovascular Imaging Systems, Inc.. The 510(k) number is K942231.

When did MICROVIEW II/MICRORAIL II CATHETERS receive FDA 510(k) clearance?

MICROVIEW II/MICRORAIL II CATHETERS received FDA 510(k) clearance on 1994-08-01, under 510(k) number K942231.

Who is the listed applicant for MICROVIEW II/MICRORAIL II CATHETERS?

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

What is the FDA product code for MICROVIEW II/MICRORAIL II CATHETERS?

The FDA product code for MICROVIEW II/MICRORAIL II CATHETERS is DQO.

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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.