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FDA 510(k)

THE OMNIGUIDE GUIDING CATHETER WITH BALLOON

K-Number: K945963 · 1995-02-08

ApplicantMicro Interventional Systems, Inc.
Decision Date1995-02-08
Product CodeDQT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

THE OMNIGUIDE GUIDING CATHETER WITH BALLOON is the device name listed in this FDA 510(k) record. The listed applicant is Micro Interventional Systems, Inc.. It received FDA 510(k) clearance on 1995-02-08 under 510(k) number K945963. The device is classified under product code DQT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THE OMNIGUIDE GUIDING CATHETER WITH BALLOON?

THE OMNIGUIDE GUIDING CATHETER WITH BALLOON is a medical device that received FDA 510(k) clearance on 1995-02-08. The listed applicant is Micro Interventional Systems, Inc.. The 510(k) number is K945963.

When did THE OMNIGUIDE GUIDING CATHETER WITH BALLOON receive FDA 510(k) clearance?

THE OMNIGUIDE GUIDING CATHETER WITH BALLOON received FDA 510(k) clearance on 1995-02-08, under 510(k) number K945963.

Who is the listed applicant for THE OMNIGUIDE GUIDING CATHETER WITH BALLOON?

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

What is the FDA product code for THE OMNIGUIDE GUIDING CATHETER WITH BALLOON?

The FDA product code for THE OMNIGUIDE GUIDING CATHETER WITH BALLOON is DQT.

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Related Devices (Code: DQT)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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